Phase 2
N=45
Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer
Anal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00324415 ↗Enrolled (actual)
45
Serious AEs
60.0%
Results posted
Sep 2015
Primary outcome: Primary: Locoregional Failure Rate at 3 Years — 42; 20 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cetuximab (Biological); cisplatin (Drug); fluorouracil (Drug); radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Locoregional Failure Rate at 3 Years |
42; 20 | — |
| SECONDARY Progression-free Survival |
87.3 | — |
| SECONDARY Relapse-free Survival |
83.1 | — |
| SECONDARY Colostomy-free Survival at 1 Year |
92.4 | — |
| SECONDARY Overall Survival |
92.8 | — |
| SECONDARY Quality of Life EORTC Global Score at 1 Year |
78.9 | — |
| SECONDARY Number of Delayed Toxicities |
5 | — |
| SECONDARY Changes in CD4 Counts During and for 1 Year After Completion of Study Treatment |
102 | — |
| SECONDARY Incidence of Opportunistic Illnesses |
4 | — |
| SECONDARY Objective Response Rate (Complete and Partial) |
30 | — |
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. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and cetuximab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin, fluorouracil, and cetuximab together with radiation therapy works in treating patients with HIV and stage I, stage II, or stage III anal cancer.
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
Data sourced from ClinicalTrials.gov (NCT00324415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.