NCT00308516

5-Fluorouracil, Bevacizumab, and Radiation Followed by Modified FOLFOX6 and Bevacizumab in Stage II/III Rectal Cancer

A Phase II Study of 5-Fluorouracil, Bevacizumab (Avastin), and Radiation in the Preoperative or Adjuvant Treatment of Patients With Stage II / III Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 week regimen. Patients with no evidence of disease following systemic therapy may continue single agent bevacizumab for up to one year. After all treatment is completed, patients will be re-evaluated with imaging to establish a new baseline. Patients will be re-evaluated thereafter for up to a total of 5 years. Combined Modality Treatment: * bevacizumab 5mg/kg IV infusion days 1, 15, and 29 * fluorouracil 225mg/m2 IV continuous infusion days 1-42 * radiation 1.8 Gy/day or 28 fractions weeks 1-6 Systemic Treatment: * 5-fluorouracil 400 mg/m2 bolus * 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15 * leucovorin 350 mg prior to FU on days 1 and 15 * oxaliplatin 85 mg/m2 days 1 and 15 * bevacizumab 5 mg/kg days 1 and 15

Conditions

• Rectal Cancer
• Cancer of the Rectum
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	5-Fluorouracil	Combined Modality Treatment: fluorouracil 225mg/m2 IV continuous infusion days 1-42 Systemic Treatment: 5-fluorouracil 400 mg/m2 bolus 5-fluorouracil 2400 mg/m2 over 46 hours days 1 and 15
DRUG	Bevacizumab	Combined Modality Treatment: bevacizumab 5mg/kg IV infusion days 1, 15, and 29 Systemic Treatment: bevacizumab 5 mg/kg days 1 and 15
PROCEDURE	Radiation Therapy	radiation 1.8 Gy/day or 28 fractions weeks 1-6
DRUG	Oxaliplatin	Systemic Treatment: oxaliplatin 85 mg/m2 days 1 and 15
DRUG	Leucovorin	Systemic Treatment: leucovorin 350 mg prior to FU on days 1 and 15

Timeline

• Start date: 2006-03-01
• Primary completion: 2009-04-01
• Completion: 2012-02-01
• First posted: 2006-03-29
• Last updated: 2021-12-10
• Results posted: 2013-05-14

Locations

14 sites across 1 country: United States