Trial Outcomes & Findings for Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery (NCT NCT00305877)
NCT ID: NCT00305877
Last Updated: 2014-05-21
Results Overview
Specific toxicities to be monitored pursuant to the primary endpoint include: 1. Any grade 5 toxicities 2. Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension 3. Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis 4. ECOG performance status decline by 2 or greater for \>24 hours 5. Weight loss \>10%
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
Every 2 weeks while on treatment and for 30 days after the end of treatment
Results posted on
2014-05-21
Participant Flow
This study was activated on February 17, 2006 and terminated on January 9, 2008 with final accrual of 137 patients.
Participant milestones
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
|---|---|---|
|
Overall Study
Treated
|
67
|
63
|
|
Overall Study
Eligible
|
66
|
66
|
|
Overall Study
STARTED
|
69
|
68
|
|
Overall Study
Included in Efficacy Analysis
|
65
|
62
|
|
Overall Study
COMPLETED
|
45
|
34
|
|
Overall Study
NOT COMPLETED
|
24
|
34
|
Reasons for withdrawal
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
9
|
|
Overall Study
Adverse Event
|
9
|
14
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Never start treatment
|
2
|
5
|
|
Overall Study
Ineligible
|
2
|
1
|
|
Overall Study
Transportation issue with daily RT
|
0
|
1
|
Baseline Characteristics
Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
Baseline characteristics by cohort
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
n=67 Participants
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
n=63 Participants
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
60 years
n=107 Participants
|
60 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Every 2 weeks while on treatment and for 30 days after the end of treatmentPopulation: All treated patients were included in this analysis.
Specific toxicities to be monitored pursuant to the primary endpoint include: 1. Any grade 5 toxicities 2. Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension 3. Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis 4. ECOG performance status decline by 2 or greater for \>24 hours 5. Weight loss \>10%
Outcome measures
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
n=67 Participants
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
n=63 Participants
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
|---|---|---|
|
Proportion of Patients With Specific Protocol Defined Adverse Event at Conclusion of All Therapy
|
0.30 Proportion of patients
Interval 0.19 to 0.42
|
0.25 Proportion of patients
Interval 0.15 to 0.38
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 yearsPopulation: Eligible and treated patients are included in this analysis.
Overall survival (OS) is defined as the time from randomization to death from any cause, or censored at last known date of survival.
Outcome measures
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
n=65 Participants
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
n=62 Participants
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
|---|---|---|
|
Two-year Overall Survival Rate
|
0.38 Proportion of patients
Interval 0.26 to 0.5
|
0.37 Proportion of patients
Interval 0.24 to 0.48
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, and every 6 months after completion of treatment for 2 years, then annually for 3 yearsPopulation: Eligible and treated patients.
Disease-free survival (DFS) is defined as the time from randomization to the first treatment failure (recurrence or death before recurrence).
Outcome measures
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
n=65 Participants
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
n=62 Participants
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
|---|---|---|
|
Two-year Disease-free Survival (DFS)
|
0.17 Proportion of patients
Interval 0.08 to 0.26
|
0.23 Proportion of patients
Interval 0.12 to 0.34
|
Adverse Events
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
Serious events: 54 serious events
Other events: 66 other events
Deaths: 0 deaths
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
Serious events: 51 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
n=67 participants at risk
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
n=63 participants at risk
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
3.0%
2/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
6.3%
4/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
37.3%
25/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
38.1%
24/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
14.9%
10/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
7/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
43.3%
29/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
55.6%
35/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
6.0%
4/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
14.3%
9/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Cardiac disorders
C-P arrest, non-fatal, cause unknown
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
4.8%
3/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
16.4%
11/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
9.5%
6/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
3.0%
2/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
3.0%
2/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
17.9%
12/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
4.5%
3/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
4.5%
3/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
4.5%
3/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
6.3%
4/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
6.0%
4/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
7.5%
5/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
4.5%
3/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Perforation, colon
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ulcer, gastric
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
3/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Hepatobiliary disorders
Hepatic-other
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ gr3-4 neut, urinary tract
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, biliary tree
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, catheter
|
3.0%
2/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, peritoneal
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection w/ unk ANC liver
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection Gr0-2 neut, blood
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Infections and infestations
Infection-other
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
3/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
9.0%
6/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
9.0%
6/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
3.0%
2/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Creatinine increased
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Confusion
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
6.3%
4/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Injury, poisoning and procedural complications
Vascular access,Thrombosis/embolism
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.0%
2/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
6.3%
4/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)
n=67 participants at risk
Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
|
Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)
n=63 participants at risk
Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
41.8%
28/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
44.4%
28/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Leukocytes decreased
|
70.1%
47/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
61.9%
39/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
17.9%
12/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
6.3%
4/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Neutrophils decreased
|
50.7%
34/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
54.0%
34/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Platelets decreased
|
53.7%
36/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
54.0%
34/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
25.4%
16/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Vascular disorders
Hypotension
|
6.0%
4/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
73.1%
49/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
76.2%
48/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Fever w/o neutropenia
|
23.9%
16/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
15.9%
10/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Psychiatric disorders
Insomnia
|
9.0%
6/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Rigors/chills
|
11.9%
8/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
7/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
25.4%
17/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
22.2%
14/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.9%
14/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.4%
15/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
19.0%
12/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
16.4%
11/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
31.3%
21/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
4.8%
3/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
83.6%
56/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
15.9%
10/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
11.9%
8/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
40.3%
27/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
14.3%
9/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
6.0%
4/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
44.8%
30/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
30.2%
19/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
20.9%
14/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
17.5%
11/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
7.5%
5/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
50.7%
34/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
46.0%
29/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
7.5%
5/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
12.7%
8/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Muco/stomatitis (symptom) oral cavity
|
31.3%
21/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
14.3%
9/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
64.2%
43/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
60.3%
38/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Taste disturbance
|
16.4%
11/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
7.9%
5/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
41.8%
28/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
20.6%
13/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
|
6.0%
4/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
12.7%
8/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Edema limb
|
10.4%
7/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
7.9%
5/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
47.8%
32/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
28.6%
18/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
40.3%
27/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
23.8%
15/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
38.8%
26/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
31.7%
20/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
47.8%
32/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
38.1%
24/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Investigations
Blood bilirubin increased
|
7.5%
5/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
4.8%
3/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.4%
19/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
15.9%
10/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.9%
14/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
11.1%
7/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
26.9%
18/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
19.4%
13/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
7.9%
5/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Renal and urinary disorders
Proteinuria
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
12.7%
8/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.4%
9/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
4.8%
3/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
13.4%
9/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
3.2%
2/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-motor
|
7.5%
5/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
0.00%
0/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Neuropathy-sensory
|
7.5%
5/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
6.3%
4/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abdomen, pain
|
32.8%
22/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
33.3%
21/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Nervous system disorders
Head/headache
|
10.4%
7/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
14.3%
9/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Joint, pain
|
0.00%
0/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
6.3%
4/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
5/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
4.8%
3/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.4%
9/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
1.6%
1/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
|
General disorders
Flu-like syndrome
|
1.5%
1/67 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
7.9%
5/63 • Assessed every 2 weeks while on treatment and for 30 days after the end of treatment
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60