Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer
Condition: Anal Cancer
MeSH terms: Anus Neoplasms
Intervention: cetuximab; cisplatin; fluorouracil; radiotherapy
Intervention description: Given IV; Given IV; Given IV; Given once daily 5 days a week for 5 weeks
Intervention MeSH terms: Cisplatin; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: squamous cell carcinoma of the anus; stage I anal cancer; stage II anal cancer; stage IIIA anal cancer; stage IIIB anal cancer; basaloid carcinoma of the anus; cloacogenic carcinoma of the anus

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 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.
    

Eligibility criteria:

        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