Colorectal Cancer Clinical Trial
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
Verified date | November 2021 |
Source | SCRI Development Innovations, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | February 2012 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Northeast Alabama Regional Medical Center | Anniston | Alabama |
United States | Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee |
United States | Consultants in Medical Oncology and Hematology | Drexel Hill | Pennsylvania |
United States | Florida Cancer Specialists | Fort Myers | Florida |
United States | Northeast Georgia Medical Center | Gainesville | Georgia |
United States | Integrated Community Oncology Network | Jacksonville | Florida |
United States | Northeast Arkansas Clinic | Jonesboro | Arkansas |
United States | Watson Clinic Center for Cancer Care and Research | Lakeland | Florida |
United States | Consultants in Blood Disorders and Cancer | Louisville | Kentucky |
United States | Wellstar Cancer Research | Marietta | Georgia |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | Peninsula Cancer Institute | Newport News | Virginia |
United States | South Texas Oncology and Hematology | San Antonio | Texas |
United States | Spartanburg Regional Medical Center | Spartanburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
SCRI Development Innovations, LLC | Genentech, Inc. |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | The Proportion of Patients Predicted to be Alive Without Evidence of Disease Recurrence 24 Months After Completion of Protocol Treatment | 24 months | |
Secondary | Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | Overall Survival (OS) is defined ad the Length of time, in months, that patients were alive from their first date of protocol treatment until death. | 24 months |
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