Status:
COMPLETED
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Anal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: 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. Mono...
Detailed Description
OBJECTIVES: Primary * Determine the 2-year local failure rate in patients with HIV-associated stage I-IIIB anal carcinoma treated with cisplatin, fluorouracil, cetuximab, and radiotherapy. * Determi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00324415
Start Date
September 1 2006
End Date
May 1 2016
Last Update
May 30 2025
Active Locations (7)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
2
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States, 90095-1793
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States, 63110