Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
Completed · Phase 2
Conditions studied: Anal Cancer
In brief
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 ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Cetuximab may help cisplatin and fluorouracil work better by making tumor cells more sensitive to the drugs. It may also make tumor cells more sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin, fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I (closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of 11/3/2008) or stage III anal cancer.
Key facts
- Study ID
- NCT00316888
- Run by
- ECOG-ACRIN Cancer Research Group
- People needed
- 63
- Starts
- 2007-02-28
- Expected to finish
- 2021-08-17
- Last updated by the study team
- 2023-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Poudre Valley Hospital — Fort Collins, Colorado, United States
- Front Range Cancer Specialists — Fort Collins, Colorado, United States
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
- Hematology and Oncology Associates — Chicago, Illinois, United States
- Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
- Kellogg Cancer Care Center — Highland Park, Illinois, United States
- Provena St. Mary's Regional Cancer Center - Kankakee — Kankakee, Illinois, United States
- North Shore Oncology and Hematology Associates, Limited - Libertyville — Libertyville, Illinois, United States
- Cancer Care and Hematology Specialists of Chicagoland - Niles — Niles, Illinois, United States
- Swedish-American Regional Cancer Center — Rockford, Illinois, United States
- Hematology Oncology Associates - Skokie — Skokie, Illinois, United States
- CCOP - Carle Cancer Center — Urbana, Illinois, United States
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- William N. Wishard Memorial Hospital — Indianapolis, Indiana, United States
- Cedar Rapids Oncology Associates — Cedar Rapids, Iowa, United States
- Mercy Regional Cancer Center at Mercy Medical Center — Cedar Rapids, Iowa, United States
- Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
- Mercy Medical Center - Sioux City — Sioux City, Iowa, United States
- St. Luke's Regional Medical Center — Sioux City, Iowa, United States
- Cancer Center of Kansas, PA - Chanute — Chanute, Kansas, United States
- Cancer Center of Kansas, PA - Dodge City — Dodge City, Kansas, United States
- Cancer Center of Kansas, PA - El Dorado — El Dorado, Kansas, United States
- Cancer Center of Kansas - Fort Scott — Fort Scott, Kansas, United States
- Cancer Center of Kansas-Independence — Independence, Kansas, United States
- Stanford Cancer Center — Stanford, California, United States
Full record on ClinicalTrials.gov
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