Status:
COMPLETED
5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Rectal Cancer
Cancer of the Rectum
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Fluoro...
Detailed Description
All eligible patients will receive combined modality treatment initially. Systemic treatment will begin 4-6 weeks after completion of the Combined Modality portion and will complete 4 cycles of a 4 we...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00308516
Start Date
March 1 2006
End Date
February 1 2012
Last Update
December 10 2021
Active Locations (14)
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1
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
2
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
3
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
4
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256