Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer
Condition: Cervical Cancer; Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Uterine Cervical Neoplasms; Immunologic Deficiency Syndromes
Intervention: cisplatin; external beam radiation therapy
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer; cervical adenocarcinoma; cervical adenosquamous cell carcinoma; cervical squamous cell carcinoma; HIV infection

Summary:

      RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together with
      radiation therapy may be an effective treatment for cervical cancer.

      PURPOSE: This trial studies how well cisplatin and radiation therapy work in treating
      participants with HIV-associated locally advanced cervical cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Participants (who have been adequately clinically staged by standard clinical
             guidelines) with primary, untreated, histologically confirmed, documented invasive
             squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine
             cervix, stages IB2, IIA, IIB, IIIA, IIIB, and IVA (Stage IIA tumors must be greater
             than 4 cm)

          -  HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or
             chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
             confirmed by a licensed western blot or a second antibody test by a method other than
             the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 ribonucleic acid
             (RNA) viral load

               -  NOTE: the term "licensed" refers to a United States (U.S) Food and Drug
                  Administration (FDA)-approved kit or for sites located in countries other than
                  the United States, a kit that has been certified or licensed by an oversight body
                  within that country and validated internally

               -  WHO (World Health Organization) and CDC (Centers for Disease Control and
                  Prevention) guidelines mandate that confirmation of the initial test result must
                  use a test that is different from the one used for the initial assessment; a
                  reactive initial rapid test should be confirmed by either another type of rapid
                  assay or an E/CIA that is based on a different antigen preparation and/or
                  different test principle (e.g., indirect versus competitive), or a western blot
                  or a plasma HIV-1 RNA viral load

          -  No participants with carcinoma of the cervical stump

        PATIENT CHARACTERISTICS:

          -  Hemoglobin ≥ 10 g/dL (6.2 mmol/L)

          -  Platelet count ≥ 100,000/mm³ (100 x 10^9/L)

          -  Absolute neutrophil count (ANC) ≥ 1000/mm³ (1.0 x 10^9/L) (participants receiving
             transfusion, erythropoietin, or myeloid growth factor support will be eligible for
             this study)

          -  Creatinine clearance ≥ 60 mL/min (1.00 mL/s) calculated by the Cockcroft-Gault
             equation for women

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper
             limit of normal (ULN)

          -  Total bilirubin ≤ 2 times ULN unless related to antiretroviral use (e.g., atazanavir
             and indinavir), then the direct bilirubin must be ≤ 2 times ULN

          -  Ability to understand and the willingness to provide informed consent to participate

          -  Karnofsky performance status of ≥ 60%

          -  Participants of childbearing potential, defined as a sexually mature woman who has not
             undergone a hysterectomy or bilateral oophorectomy or has not been naturally
             postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in
             the preceding 24 consecutive months), must have a negative urine or serum pregnancy
             test within 3 weeks prior to enrollment and agree to use an effective form of
             contraception (e.g., barrier contraception, highly effective hormonal contraception)

          -  Life expectancy of greater than 12 months

          -  No acute active (such as tuberculosis or malaria), serious, uncontrolled infection;
             participants with a CD4 count < 50/mm³ (0.05 x 10^9/L) will be excluded if they have
             had an opportunistic infection within the past 3 months, or if there is evidence of
             resistance to antiretroviral therapy (i.e., HIV viral load ≥ 400 copies/mL despite
             combination antiretroviral therapy for at least 4 months)

          -  No prior invasive malignancy other than LACC diagnosed within the past 24 months,
             excluding anal intraepithelial neoplasia, non-melanoma skin carcinoma, or Kaposi
             sarcoma that has not required systemic chemotherapy within the past 24 months

          -  No pregnancy or breast-feeding

          -  No medical or psychiatric illness that precludes ability to give informed consent or
             is likely to interfere with the ability to comply with the protocol stipulations

          -  No participants with circumstances that will not permit completion of the study or
             required follow-up; for instance, if travel to and from treatment site is an issue

          -  No participants with cardiovascular disease manifested as:

               -  History of myocardial infarction

               -  Unstable angina

               -  Currently taking medication for treatment of angina

               -  History of coronary artery bypass surgery

               -  New York Heart Association class 3 or 4 heart failure

        PRIOR CONCURRENT THERAPY:

          -  See Patient Characteristics

          -  All patients must be prescribed combination antiretroviral therapy with the goal of
             virological suppression using an acceptable regimen that adheres to national
             guidelines for treatment of HIV infection

               -  Non-suppressed, treatment-experienced patients, defined as patients with a viral
                  load > 400 copies/mL who have been on antiretroviral therapy for more than 4
                  months, can be enrolled if a genotype assay is performed and an acceptable
                  regimen is prescribed based on the genotyping results

          -  Patients who undergo emergency radiation therapy prior to enrollment may participate
             at the investigator's discretion

          -  No participants who have undergone hysterectomy

          -  No concurrent intensity-modulated radiotherapy or interstitial brachytherapy