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

Information source: SCRI Development Innovations, LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Cancer; Cancer of the Rectum; Colorectal Cancer

Intervention: 5-Fluorouracil (Drug); Bevacizumab (Drug); Radiation Therapy (Procedure); Oxaliplatin (Drug); Leucovorin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: SCRI Development Innovations, LLC

Official(s) and/or principal investigator(s):
David R. Spigel, MD, Principal Investigator, Affiliation: SCRI Development Innovations, LLC

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.

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Disease-Free Survival (DFS), The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment

Secondary outcome: Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Northeast Alabama Regional Medical Center, Anniston, Alabama 36207, United States

Northeast Arkansas Clinic, Jonesboro, Arkansas 72401, United States

Florida Cancer Specialists, Fort Myers, Florida 33901, United States

Integrated Community Oncology Network, Jacksonville, Florida 32256, United States

Watson Clinic Center for Cancer Care and Research, Lakeland, Florida 33805, United States

Northeast Georgia Medical Center, Gainesville, Georgia 30501, United States

Wellstar Cancer Research, Marietta, Georgia 30060, United States

Consultants in Blood Disorders and Cancer, Louisville, Kentucky 40207, United States

Consultants in Medical Oncology and Hematology, Drexel Hill, Pennsylvania 19026, United States

Spartanburg Regional Medical Center, Spartanburg, South Carolina 29303, United States

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee 37404, United States

Tennessee Oncology, Nashville, Tennessee 37205, United States

South Texas Oncology and Hematology, San Antonio, Texas 78258, United States

Peninsula Cancer Institute, Newport News, Virginia 23601, United States

Additional Information

Related publications:

Spigel DR, Bendell JC, McCleod M, Shipley DL, Arrowsmith E, Barnes EK, Infante JR, Burris HA 3rd, Greco FA, Hainsworth JD. Phase II study of bevacizumab and chemoradiation in the preoperative or adjuvant treatment of patients with stage II/III rectal cancer. Clin Colorectal Cancer. 2012 Mar;11(1):45-52. doi: 10.1016/j.clcc.2011.04.002. Epub 2011 Aug 15.

Starting date: March 2006
Last updated: May 14, 2013

Page last updated: August 20, 2015

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