Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer

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Brief Title

Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer

Official Title

Phase II Trial of Combined Modality Therapy Plus Cetuximab in HIV-Associated Anal Carcinoma

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. 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.

Detailed Description



        -  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.


        -  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

      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.

Study Phase

Phase 2

Study Type


Primary Outcome

Local Failure Rate at 3 Years

Secondary Outcome

 Progression-free Survival


Anal Cancer



Study Arms / Comparison Groups

 CMT with Radiation Therapy
Description:  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)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 2006

Completion Date

May 2016

Primary Completion Date

April 2014

Eligibility Criteria


          -  Histologically confirmed stage I-IIIB invasive anal canal or perianal (anal margin)
             squamous cell carcinoma, including tumors with any of the following nonkeratinizing

               -  Basaloid

               -  Transitional cell

               -  Cloacogenic

          -  Documented HIV infection by 1 of the following:

               -  Antibody detection

               -  Culture

               -  Quantitative assay of plasma HIV RNA


          -  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

          -  No peripheral neuropathy > grade 1

          -  No severe or poorly controlled diarrhea

          -  No medical or psychiatric illness that would preclude study requirements


          -  No prior chemotherapy or radiotherapy for this malignancy

               -  Prior radiotherapy for another condition (e.g., Kaposi's sarcoma) allowed




18 Years - 120 Years

Accepts Healthy Volunteers



Joseph A. Sparano, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

AIDS Malignancy Consortium


 National Cancer Institute (NCI)

Study Sponsor

Joseph A. Sparano, MD, Study Chair, Albert Einstein College of Medicine

Verification Date

May 2018