Trial Outcomes & Findings for CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater (NCT NCT01202409)
NCT ID: NCT01202409
Last Updated: 2020-02-21
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
up to 100 weeks
Results posted on
2020-02-21
Participant Flow
Participant milestones
| Measure |
Capecitabine + Panitumumab + Oxaliplatin
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Capecitabine + Panitumumab + Oxaliplatin
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Ineligible - KRAS mutants
|
7
|
Baseline Characteristics
CAPOX in KRAS Wild-Type Advanced Adenocarcinoma of the Small Bowel or Ampulla of Vater
Baseline characteristics by cohort
| Measure |
Capecitabine + Panitumumab + Oxaliplatin
n=19 Participants
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Age, Continuous
|
60 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 100 weeksPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Capecitabine + Panitumumab + Oxaliplatin
n=19 Participants
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
|
|---|---|
|
Response Rate (RR)
|
19 Participants
|
SECONDARY outcome
Timeframe: 7.6 monthsTime interval in months from date of first treatment until the date of first documented progression of participants.
Outcome measures
| Measure |
Capecitabine + Panitumumab + Oxaliplatin
n=13 Participants
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
|
|---|---|
|
Overall Progression-free Survival (PFS) for CAPOX and Panitumumab
|
2.4 months
Interval 1.0 to 7.6
|
Adverse Events
Capecitabine + Panitumumab + Oxaliplatin
Serious events: 2 serious events
Other events: 19 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Capecitabine + Panitumumab + Oxaliplatin
n=19 participants at risk
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
|
|---|---|
|
Infections and infestations
Skin Infection
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
Other adverse events
| Measure |
Capecitabine + Panitumumab + Oxaliplatin
n=19 participants at risk
Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Investigations
Alanine Aminotransferase increased
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Investigations
Alkaline phosphatase increased
|
15.8%
3/19 • Adverse event collection from date of first treatment to 8 years
|
|
Blood and lymphatic system disorders
Anemia
|
21.1%
4/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Anorexia
|
21.1%
4/19 • Adverse event collection from date of first treatment to 8 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Investigations
Aspartate aminotransferase increased
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Dehydration
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Eye disorders
Dry Eye
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Nervous system disorders
Dysesthesia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Nervous system disorders
Dysgeusia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
General disorders
Edema limbs
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Eye disorders
Eye disorders - other
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
General disorders
Fatigue
|
26.3%
5/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.8%
3/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
31.6%
6/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Vascular disorders
Hypotension
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Gastrointestinal disorders
Mucositis oral
|
15.8%
3/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Nail infection
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Adverse event collection from date of first treatment to 8 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Palmmar-plantar erythrodysesthesia syndrome
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
21.1%
4/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
26.3%
5/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
57.9%
11/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders - Other
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disoreders - Other
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Infections and infestations
Skin infection
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Nervous system disorders
Syncope
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Vascular disorders
Thromboembolic event
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
5.3%
1/19 • Adverse event collection from date of first treatment to 8 years
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
|
Investigations
Weight loss
|
10.5%
2/19 • Adverse event collection from date of first treatment to 8 years
|
Additional Information
Dr. Michael J Overman/ Professor, GI Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-745-4317
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place