Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer

Not Recruiting

Trial ID: NCT00316888


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.

Official Title

Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor



   - 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


   - 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

   - 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

   - Pregnant or nursing


biological: cetuximab

drug: fluorouracil

drug: cisplatin

radiation: radiotherapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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