Trial Outcomes & Findings for Bevacizumab, Fluorouracil, Leucovorin Calcium, and Oxaliplatin Before Surgery in Treating Patients With Stage II-III Rectal Cancer (NCT NCT01871571)
NCT ID: NCT01871571
Last Updated: 2026-07-01
Results Overview
Pathological Complete Response (pCR) after neoadjuvant therapy in pathological specimen. Pathological Complete Response (pCR) is the absence of all invasive cancer in the breast and lymph nodes after neoadjuvant therapy, meaning all cancer cells are eliminated. This outcome is a strong predictor of improved survival. Evaluating pCR provides a rapid assessment of a patient's likely response to therapy and can help guide future treatment decisions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2026-07-01
Participant Flow
Recruitment for this study opened in August 2013 and closed in March 2018. All subjects were seen and treated in the medical clinics at the University of Southern California and Los Angeles General Medical Center.
Participant milestones
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Bevacizumab, Fluorouracil, Leucovorin Calcium, and Oxaliplatin Before Surgery in Treating Patients With Stage II-III Rectal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 Participants
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=9 Participants
|
|
Performance Status: ECOG
0
|
0 Participants
n=9 Participants
|
|
Performance Status: ECOG
1
|
17 Participants
n=9 Participants
|
|
Performance Status: ECOG
2
|
0 Participants
n=9 Participants
|
|
Performance Status: ECOG
3
|
0 Participants
n=9 Participants
|
|
Stage
IIA
|
6 Participants
n=9 Participants
|
|
Stage
IIIA
|
2 Participants
n=9 Participants
|
|
Stage
IIIB
|
9 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPathological Complete Response (pCR) after neoadjuvant therapy in pathological specimen. Pathological Complete Response (pCR) is the absence of all invasive cancer in the breast and lymph nodes after neoadjuvant therapy, meaning all cancer cells are eliminated. This outcome is a strong predictor of improved survival. Evaluating pCR provides a rapid assessment of a patient's likely response to therapy and can help guide future treatment decisions.
Outcome measures
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 Participants
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants With Pathological Complete Response (pCR) to Neoadjuvant Therapy
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 Participants
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Tumor Regression on Mesorectal Margins (Pathologic Stage Lower Than Clinical Stage)
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsNumber of cancer patients who experience a return of their cancer in the original tumor site or in the nearby lymph nodes following initial treatment. It is a measure of how often cancer returns to the local area where it started, rather than spreading to distant organs.
Outcome measures
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 Participants
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Rate of Locoregional Recurrence
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsIncidence and nature of adverse events (AEs) according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 ( v4)
Outcome measures
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 Participants
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
17 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 Participants
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants With Serious AEs (SAEs) According to NCI CTCAE v4.0
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsOutcome measures
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 Participants
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number of Participants of AEs of Special Interest for Bevacizumab (Grades) According to NCI CTCAE v4.0
|
2 Participants
|
Adverse Events
Treatment (Bevacizumab, mFOLFOX7)
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 participants at risk
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Nervous system disorders
Paresthesia
|
11.8%
2/17 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.8%
2/17 • Up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.9%
1/17 • Up to 3 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
11.8%
2/17 • Up to 3 years
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
5.9%
1/17 • Up to 3 years
|
|
Infections and infestations
Catheter related infection
|
5.9%
1/17 • Up to 3 years
|
Other adverse events
| Measure |
Treatment (Bevacizumab, mFOLFOX7)
n=17 participants at risk
Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, leucovorin calcium IV, and fluorouracil IV continuously over 46-48 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Within 6-8 weeks after treatment, patients undergo surgery.
bevacizumab: Given IV
oxaliplatin: Given IV
leucovorin calcium: Given IV
fluorouracil: Given IV
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
35.3%
6/17 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
1/17 • Up to 3 years
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
17.6%
3/17 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
17.6%
3/17 • Up to 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
76.5%
13/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
2/17 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
17.6%
3/17 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
1/17 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
41.2%
7/17 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
2/17 • Up to 3 years
|
|
Investigations
Creatinine increased
|
5.9%
1/17 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
52.9%
9/17 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
11.8%
2/17 • Up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17 • Up to 3 years
|
|
Gastrointestinal disorders
Dysgeusia
|
11.8%
2/17 • Up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.6%
3/17 • Up to 3 years
|
|
General disorders
Fatigue
|
70.6%
12/17 • Up to 3 years
|
|
Infections and infestations
Gum infection
|
5.9%
1/17 • Up to 3 years
|
|
Nervous system disorders
Headache
|
29.4%
5/17 • Up to 3 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.9%
1/17 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
11.8%
2/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.3%
6/17 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
88.2%
15/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.9%
1/17 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • Up to 3 years
|
|
Psychiatric disorders
Insomnia
|
17.6%
3/17 • Up to 3 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
5.9%
1/17 • Up to 3 years
|
|
General disorders
Malaise
|
5.9%
1/17 • Up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
23.5%
4/17 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
5.9%
1/17 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
17/17 • Up to 3 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.9%
1/17 • Up to 3 years
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
35.3%
6/17 • Up to 3 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
5.9%
1/17 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain
|
5.9%
1/17 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
11.8%
2/17 • Up to 3 years
|
|
Nervous system disorders
Paresthesia
|
82.4%
14/17 • Up to 3 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
47.1%
8/17 • Up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
17.6%
3/17 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Up to 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
64.7%
11/17 • Up to 3 years
|
|
Gastrointestinal disorders
Rectal pain
|
23.5%
4/17 • Up to 3 years
|
|
Infections and infestations
Salivary gland infection
|
5.9%
1/17 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.9%
1/17 • Up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
5.9%
1/17 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
5/17 • Up to 3 years
|
|
Investigations
White blood cell decreased
|
17.6%
3/17 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.9%
1/17 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place