Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AIDS Malignancy Clinical Trials Consortium
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT01590017
First received: May 1, 2012
Last updated: August 27, 2014
Last verified: August 2014

May 1, 2012
August 27, 2014
April 2014
October 2016   (final data collection date for primary outcome measure)
  • Treatment completion rate using the binomial proportion and its 95% confidence interval [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Adverse events as graded by the National Cancer Institute Common Terminology Criteria (CTC) version 4.0 will be tabulated [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Treatment completion rate using the binomial proportion and its 95% confidence interval [ Designated as safety issue: No ]
  • Adverse events as graded by the National Cancer Institute Common Terminology Criteria (CTC) version 4.0 will be tabulated [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01590017 on ClinicalTrials.gov Archive Site
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Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer
Feasibility Study of Safety, Toxicity, and Compliance of Concomitant Chemoradiotherapy for HIV-Associated Locally-Advanced Cervical Cancer

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.

OBJECTIVES:

Primary

  • To determine if it is feasible to administer a regimen of cisplatin/radiotherapy in HIV-infected women with locally advanced cervical cancer (LACC) on antiretroviral therapy (ART).
  • To evaluate the safety and tolerability of concomitant chemoradiotherapy with cisplatin in HIV-infected women with LACC who are also receiving concomitant ART.

Secondary

  • To determine the 1-year progression-free survival (PFS) of HIV-infected women with LACC Stage IB, II, III, or IVA who receive weekly cisplatin concomitant with radiotherapy and ART. (Exploratory)
  • To describe the quality of life (QOL) of enrolled participants via assessments before, immediately after, and at 3 and 9 months after completion of therapy, using QOL metrics that have been validated in similar populations. (Exploratory)
  • To describe the effects of treatment on participants' CD4 counts, HIV viral load, and concurrent AIDS-defining conditions. (Exploratory)
  • To describe cervical cancer recurrence patterns in HIV-infected participants with LACC defined as loco-regional and/or distant recurrences. (Exploratory)
  • To determine 1-year overall survival and causes of death (i.e., cancer-related, HIV-related, or other). (Exploratory)
  • To collect serum, cytology, and tissue for future studies specific to cervical and anal disease. (Exploratory)
  • To evaluate the effects of weekly cisplatin concomitant with radiotherapy on adherence to ART. (Exploratory)

OUTLINE: This is a multicenter study.

Participants receive cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36 (6 weeks total). Participants also undergo whole pelvic radiotherapy (WPRT) 5 days a week for 5 weeks followed by intracavitary brachytherapy.

Participants complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30 and the Cervical Cancer Module (QLQ-CX24) at baseline and periodically during study treatment.

After completion of study treatment, participants are followed up every 3 months for 12 months.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Cancer
  • Acquired Immunodeficiency Syndrome
  • Drug: cisplatin
  • Radiation: external beam radiation therapy
Experimental: Cistplatin and Radiation Therapy
Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).
Interventions:
  • Drug: cisplatin
  • Radiation: external beam radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
October 2016
October 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
South Africa
 
NCT01590017
AMC-081, CDR0000732629, U01CA121947
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
  • National Cancer Institute (NCI)
  • The EMMES Corporation
Principal Investigator: Mark H. Einstein, MD, MS Albert Einstein College of Medicine of Yeshiva University
AIDS Malignancy Clinical Trials Consortium
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP