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

Learn more about:
Related Clinical Trial
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers Assessment of Patients’ Quality of Sexual Life After Anal Cancer Treatment Neoadjuvant PD-1 Blockade Combined With Chemotherapy Followed by Concurrent Immunoradiotherapy for Locally Advanced Anal Canal Squamous Carcinoma Patients Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5) Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors Detecting HPV DNA in Anal and Cervical Cancers ANCA II – Quality of Life and Functional Outcome in Patients With Anal Cancer RTX-321 Monotherapy in Patients With HPV 16+ Tumors Anal Injury Screening for High Risk HPV M7824 in Subjects With HPV Associated Malignancies Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer Avastin/[18-F]-5-fluorouracil PET/CT Imaging Feasibility Project Assessment of Health Related Quality of Life in Patients Treated for Rectal Cancer Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies Function Following Laser for Anal Intraepithelial Neoplasia (FLAN) A Message Framing Intervention for Increasing Parental Acceptance of Human Papillomavirus Vaccination Anal Sphincter Prosthesis in Treating Patients Who Are Undergoing Surgery for Anal or Rectal Cancer Phase 2 Study of ADXS11-001 in Subjects With Carcinoma of the Anorectal Canal Pilot Study to Determine the Safety and Efficacy of Gardasil Against the Human Papilloma Virus (HPV) in HIV-infected Men Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery? Drainage Seton With Flap Versus EAS Preserving Seton in Treatment of Transsphincteric Anal Fistula HPV-SAVE: 9-Valent HPV Vaccine for High-Grade Anal Dysplasia Radiation Dosimetry Study Comparing 2 Different Patient Setups in Anal/Rectal Cancer Patients Comparing Two Types of Swabs in Collecting Cell Samples for Anal Pap Tests and Human Papillomavirus Tests in Men Who Have Sex With Men The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men High-Resolution Anoscopy Perceived Discomfort Study Infrared Coagulator Ablation or Observation in Preventing Anal Cancer in HIV-Positive Patients With Anal Neoplasia Image Fusion PET, CT and 3D-ultrasound Examinations Hybrid Capture 2 Human Papiloma Virus (HPV) High-Risk Anal DNA Test ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV Molecular Genetic and Pathological Studies of Anal Tumors Intensity-Modulated Radiation Therapy, Fluorouracil, and Mitomycin C in Treating Patients With Invasive Anal Cancer Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer QOL & Functional Outcomes After Combined Modality Tx for Anal CA: Comparison of Conventional vs IMRT A Study of mDCF in Combination or Not With Atezolizumab in Advanced Squamous Cell Anal Carcinoma Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer Topical MTS-01 for Dermatitis During Radiation and Chemotherapy for Anal Cancer Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy Screening for HIV-Associated Anal Cancer Combined Modality Therapy for Patients With With HIV and Stage I, Stage II, or Stage III Anal Cancer Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer Study of IMRT Radiotherapy Concurrent Chemothrerapy for Anal Cancer A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE) Radiation Therapy Plus Fluorouracil With or Without Additional Chemotherapy in Treating Patients With Primary Anal Cancer Prospective Cohort on Quality of Sexual Life Among Men Who Have Sex With Men Treated for Anal Cancer With Concurrent Chemotherapy and Intensity-modulated Radiotherapy Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Anal Cancer Radiotherapy Study Radiation Therapy, Mitomycin, and Either Fluorouracil or Cisplatin in Treating Patients With Locally Advanced Anal Cancer Radiation Therapy, Cisplatin, Fluorouracil, and Cetuximab in Treating Patients With Locally Advanced Anal Cancer Individual Following in Anal Cancer With PET/CT Anal Cancer Screening Study The Prevent Anal Cancer Self-Swab Study Shared Decision Making With Anal Cancer Patients on Radiation Dose Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy Quality of Life in Patients With Anal Cancer Functional Outcomes Following Anal Cancer Treatment Pembrolizumab in Refractory Metastatic Anal Cancer A Phase I/II Evaluation of ADXS11-001, Mitomycin, 5-fluorouracil (5-FU) and IMRT for Anal Cancer

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

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Local Failure Rate at 3 Years

Secondary Outcome

 Progression-free Survival

Condition

Anal Cancer

Intervention

cetuximab

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)

Publications

* 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

Biological

Estimated Enrollment

45

Start Date

September 2006

Completion Date

May 2016

Primary Completion Date

April 2014

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
      

Gender

All

Ages

18 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Joseph A. Sparano, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00324415

Organization ID

AMC-045

Secondary IDs

U01CA070019

Responsible Party

Sponsor

Study Sponsor

AIDS Malignancy Consortium

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

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


Verification Date

May 2018