5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer
Completed · Phase 2
Conditions studied: Rectal Cancer, Cancer of the Rectum, Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT00308516
- Run by
- SCRI Development Innovations, LLC
- People needed
- 66
- Starts
- 2006-03-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2021-12-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northeast Alabama Regional Medical Center — Anniston, Alabama, United States
- Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Integrated Community Oncology Network — Jacksonville, Florida, United States
- Watson Clinic Center for Cancer Care and Research — Lakeland, Florida, United States
- Northeast Georgia Medical Center — Gainesville, Georgia, United States
- Wellstar Cancer Research — Marietta, Georgia, United States
- Consultants in Blood Disorders and Cancer — Louisville, Kentucky, United States
- Consultants in Medical Oncology and Hematology — Drexel Hill, Pennsylvania, United States
- Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
- Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- South Texas Oncology and Hematology — San Antonio, Texas, United States
- Peninsula Cancer Institute — Newport News, Virginia, United States
Full record on ClinicalTrials.gov
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