Phase 2
N=66
5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer
Rectal Cancer · Cancer of the Rectum · Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00308516 ↗Enrolled (actual)
66
Serious AEs
50.0%
Results posted
May 2013
Primary outcome: Primary: Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment — 85; 97 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5-Fluorouracil (Drug); Bevacizumab (Drug); Radiation Therapy (Procedure); Oxaliplatin (Drug); Leucovorin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment |
85; 97 | — |
| SECONDARY Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death |
NA; NA | — |
Summary
This phase II trial will investigate the combination of adjuvant 5-fluorouracil, radiation, and bevacizumab in patients with stage II and III rectal cancer, followed by FOLFOX6 and bevacizumab. Fluorouracil (FU) has proven to be an effective and safe regimen in the treatment of stage II and III rectal cancer. Recent evidence has proven fluorouracil/leucovorin (FL) in combination with bevacizumab is superior to FL alone and when combined with irinotecan is superior to (irinotecan plus fluorouracil/leucovorin (IFL) alone. This trial will be one of the first clinical trials to evaluate a combination of targeted therapy, radiation, and chemotherapy in the adjuvant treatment of a common solid tumor.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed Stage I or II rectal cancer
- Patients must be candidates for preoperative or adjuvant chemoradiation.
- Patients enrolling in the adjuvant chemoradiation cohort must have undergone surgical resection of the primary rectal tumor between 28 and 56 days (i.e., 4-8 weeks) prior to study treatment.
- ECOG performance status 0-1
- Adequate bone marrow, liver, and kidney function
- At least 18 years of age
- Able to give written informed consent
Exclusion Criteria
- Treatment with prior chemotherapy or radiation for rectal cancer
- History of myocardial infarction
- Uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication or peripheral vascular disease
- History of stroke within 6 months
- History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess within 6 months
- Symptomatic sensory or peripheral neuropathy
- Prior treatment with anti-angiogenic agents
- Prior malignancy in the past 5 years
- Active infections or serious underlying medical condition
- Major surgery less than 28 days prior
- Women who are pregnant or lactating
- Thrombolytic therapy within 10 days of starting bevacizumab
- PEG tube, G-tube, or external biliary stents
- Proteinuria
- Non healing wound, ulcer or fracture
- History of bleeding diathesis or coagulopathy
- Hemoptysis
- Participation in another experimental trial within 28 days
- Uncontrolled anticoagulant therapy
Data sourced from ClinicalTrials.gov (NCT00308516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.