Status:
COMPLETED
Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
Lead Sponsor:
ECOG-ACRIN Cancer Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ...
Detailed Description
OBJECTIVES: Primary Objective: * Determine whether the addition of cetuximab to combined modality therapy (CMT) comprising cisplatin, fluorouracil, and radiotherapy reduces the local failure rate by...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histologically confirmed anal canal or perianal (anal margin) squamous cell carcinoma
- Stage I-IIIB (closed to accrual as of 11/3/2008)
- Stage II (T3, N0 only), IIIA, or IIIB
- Tumors of nonkeratinizing histology, such as basaloid, transitional cell, or cloacogenic histology, allowed
- No well-differentiated stage I anal margin cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 100,000/mm\^3
- Absolute neutrophil count \> 1,500/mm\^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance \> 60 mL/min
- Bilirubin ≤ 2 times ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 times ULN
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
- No other malignancies except nonmelanomatous skin cancer
- Prior malignancies must be in remission for ≥ 5 years
- Patients with a known risk factor for human immunodeficiency virus (HIV) infection must undergo HIV testing within 90 days before study entry AND must be HIV negative by antibody detection, culture, or quantitative assay of plasma HIV ribonucleic acid (RNA)
- EXCLUSION CRITERIA:
- Presence of the following conditions within the past 6 months:
- Active infection
- Uncontrolled diabetes
- New York Heart Association class II-IV congestive heart failure
- Cerebrovascular accident
- Transient ischemic attack
- Uncontrolled hypertension
- Unstable angina
- Myocardial infarction
- History of rheumatic disorders, irritable bowel syndrome, or inflammatory bowel disease
- Known HIV positivity
- Known risk factors for HIV infection
- Prior radiotherapy or chemotherapy for this malignancy
- Prior pelvic radiotherapy
- Prior potentially curative surgery (i.e., abdominal or peritoneal resection) for anal cancer
- Pregnant or nursing
Exclusion
Key Trial Info
Start Date :
February 28 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 17 2021
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00316888
Start Date
February 28 2007
End Date
August 17 2021
Last Update
June 29 2023
Active Locations (125)
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1
Stanford Cancer Center
Stanford, California, United States, 94305-5824
2
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
3
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
4
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013