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

NCT01590017 | Completed Phase 2 Results

• 3 other identifiers: AMC-081CDR0000732629UM1CA121947
• Study Type: interventional
• Target: 41
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Cervical Cancer; Acquired Immunodeficiency Syndrome

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

Outcome Measures

Primary Outcomes (2)

• Treatment Completion Rate

  Number of participants who completed therapy

  8 weeks

• Patients With Adverse Events

  Number of patients who experienced one or more adverse events

  12 months

Study Arms (1)

Cistplatin and Radiation Therapy

EXPERIMENTAL

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).

Drug: cisplatin; Radiation: external beam radiation therapy

Interventions

cisplatin DRUG

Cistplatin and Radiation Therapy

external beam radiation therapy RADIATION

Cistplatin and Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator
• University of Arkansas: collaborator
• Montefiore Medical Center: collaborator

Study Sites (2)

Clinical HIV Research Unit, a Division of the Wits Health Consortium (Pty) Ltd

Johannesburg, 2092, South Africa

Location

University of Zimbabwe Clinical Research Centre / Parirenyatwa Hospital

Harare, Zimbabwe

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Jeannette Lee, PhD.
• Organization: AMC Statistical Center

jylee@uams.edu

501-526-6712

Study Officials

• Mark H. Einstein, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 2, 2012
• Study Start: April 1, 2014
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: July 27, 2022
• Results First Posted: August 7, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); ZI (1)