Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
Anal Cancer
About this trial
This is an interventional treatment trial for Anal Cancer focused on measuring stage I anal cancer, stage II anal cancer, stage IIIA anal cancer, stage IIIB anal cancer, squamous cell carcinoma of the anus, basaloid carcinoma of the anus, cloacogenic carcinoma of the anus
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage I-IIIB invasive anal canal or perianal (anal margin) squamous cell carcinoma, including tumors with any of the following nonkeratinizing histologies: Basaloid Transitional cell Cloacogenic Documented HIV infection by 1 of the following: Antibody detection Culture Quantitative assay of plasma HIV RNA PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL (transfusions, epoetin alfa, or myeloid growth factor support allowed provided blood counts are stable for ≥ 2 weeks prior to study entry) Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 60 mL/min AST and ALT ≤ 3 times ULN Bilirubin ≤ 2 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No acute active, serious, uncontrolled opportunistic infection No other prior invasive malignancy diagnosed within the past 24 months, excluding in situ cervical cancer, anal dysplasia or carcinoma in situ, nonmelanoma skin carcinoma, or Kaposi's sarcoma that has not required systemic chemotherapy within the past 24 months No peripheral neuropathy > grade 1 No severe or poorly controlled diarrhea No medical or psychiatric illness that would preclude study requirements PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy for this malignancy Prior radiotherapy for another condition (e.g., Kaposi's sarcoma) allowed
Sites / Locations
- Rebecca and John Moores UCSD Cancer Center
- UCLA Clinical AIDS Research and Education (CARE) Center
- Beth Israel Deaconess Medical Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Joan Karnell Cancer Center at Pennsylvania Hospital
- Benaroya Research Institute at Virginia Mason Medical Center
Arms of the Study
Arm 1
Experimental
CMT with Radiation Therapy
All patients will receive combined modality therapy (CMT) with 2 cycles of cisplatin and 5-FU chemotherapy, given concurrently with radiation therapy. CMT consists of: Cetuximab 400 mg/m2 IV Day -7 (1 week before the cycle 1, Day 1 cisplatin/5-FU and RT), then 250 mg/m2 IV Days 1, 8, 15, 22, 29, 36 and 43 (a minimum of 6 and a maximum of 8 doses of cetuximab will be administered, including the loading dose). Cisplatin 75 mg/m2 IV on Day 1 (cycle 1) and Day 29 (cycle 2) 5-FU 1000 mg/m2/day by continuous intravenous infusion on Days 1-4 (cycle 1) and Days 29-32 (cycle 2)