Cisplatin, Fluorouracil, Cetuximab, and Radiation Therapy in Treating Patients With HIV and Stage I, Stage II, or Stage III Anal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
AIDS Malignancy Clinical Trials Consortium
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00324415
First received: May 10, 2006
Last updated: June 18, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anal Cancer |
Biological: cetuximab Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Combined Modality Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma |
Resource links provided by NLM:
Further study details as provided by AIDS Malignancy Clinical Trials Consortium:
Primary Outcome Measures:
- Local failure rate at 3 years [ Time Frame: 3 years following treatment discontinuation ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Up to 5 years following treatment discontinuation ] [ Designated as safety issue: No ]
- Relapse-free survival [ Time Frame: Up to 5 years after treatment discontinuation ] [ Designated as safety issue: No ]
- Colostomy-free survival [ Time Frame: Up to 5 years following treatment discontinuation ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Up to 5 years following treatment discontinuation ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 3 years following treatment discontinuation ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 90 days following treatment discontinuation ] [ Designated as safety issue: Yes ]
- Changes in viral load and CD4 counts during and for 1 year after completion of study treatment [ Time Frame: 1 year following treatment discontinuation ] [ Designated as safety issue: No ]
- Incidence of opportunistic illnesses, including the development of AIDS during and for 1 year after completion of study treatment [ Time Frame: 1 year following treatment discontinuation ] [ Designated as safety issue: No ]
- Anogenital human papilloma virus (HPV) infection and anal cytology [ Time Frame: 6 months following treatment discontinuation ] [ Designated as safety issue: No ]
- Objective response rate (complete and partial) [ Time Frame: 3 years following treatment discontinuation ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: cetuximab
- 5-FU
- Adrucil
- Carac
- Efudex
- Fluoroplex
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)
Other Name: Erbitux
Drug: cisplatin
75 mg/m2 IV on Day 1 (cycle 1) and Day 29 (cycle 2)
Other Name: Platinol
Drug: fluorouracil
1000 mg/m2/day by continuous intravenous infusion on Days 1-4 (cycle 1) and Days 29-32 (cycle 2)
Other Names:
Radiation: radiation therapy
Irradiation to tumor site and inguinal nodes beginning on cycle 1, Day 1 cisplatin/5-FU (minimum 45.0 Gy [5 weeks if given on schedule and without interruption], maximum 54.0 Gy [6 weeks if given on schedule and without interruption). IMRT may be used at the discretion of the treating physician.
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.
- Determine the objective response rate (complete and partial), progression-free survival, relapse-free survival, colostomy-free survival, overall survival, quality of life, and overall toxicity in patients treated with this regimen.
Secondary
- Characterize the effect of this regimen on the underlying HIV condition by describing changes in viral load, CD4 counts, and the incidence of opportunistic illnesses, including the development of AIDS during and in the first year after treatment.
- Evaluate the effect of this regimen on anogenital human papilloma virus (HPV) infection and anal cytology.
OUTLINE: This is an open-label, multicenter study.
Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 35*, fluorouracil IV continuously on days 1-4 and 29-32, and cisplatin IV over 1 hour on days 1 and 29. Beginning on day 1, patients undergo concurrent radiotherapy to the primary tumor 5 days a week for 5-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receiving 7 weeks of radiotherapy also receive cetuximab on days 42 and 49.
Quality of life is assessed at baseline, at the completion of study treatment, and then at months 3, 6, 12, 24, and 36.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324415
Locations
| United States, California | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| UCLA Clinical AIDS Research and Education (CARE) Center | |
| Los Angeles, California, United States, 90095-1793 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Bronx, New York, United States, 10461 | |
| United States, Pennsylvania | |
| Joan Karnell Cancer Center at Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19106 | |
| United States, Washington | |
| Benaroya Research Institute at Virginia Mason Medical Center | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
Investigators
| Study Chair: | Joseph A. Sparano, MD | Albert Einstein College of Medicine of Yeshiva University |
| Principal Investigator: | Lisa A. Kachnic, MD | Massachusetts General Hospital |
| Principal Investigator: | David M. Aboulafia, MD | Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT00324415 History of Changes |
| Other Study ID Numbers: | CDR0000440065, U01CA070019, AMC-045 |
| Study First Received: | May 10, 2006 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration United States: Federal Government |
Keywords provided by AIDS Malignancy Clinical Trials Consortium:
|
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 |
Additional relevant MeSH terms:
|
Anus Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Anus Diseases Rectal Diseases |
Cetuximab Cisplatin Fluorouracil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013