Cisplatin and Radiation Therapy With or Without Triapine in Treating Patients With Previously Untreated Stage IB-IVA Cervical Cancer or Stage II-IVA Vaginal Cancer

Cervical Adenocarcinoma Clinical Trial

Official title: Randomized Phase II Study of Intravenous 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine® NSC #663249) Cisplatin-Radiochemotherapy Versus Intravenous Cisplatin-Radiochemotherapy in Women Diagnosed With Stage IB-IVA Cervical Cancer and Stage II-IVA Vaginal Cancer

Status Active, not recruiting

Clinical Trial Summary

This randomized phase II trial studies how well cisplatin and radiation therapy with or without triapine work in treating patients with previously untreated stage IB-IVA cervical cancer or stage II-IVA vaginal cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x rays to kill tumor cells. Triapine may make tumor cells more sensitive to radiation therapy. It is not yet known whether cisplatin and radiation therapy is more effective when given with or without triapine in treating cervical or vaginal cancer.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the posttherapy 3-month fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) complete metabolic response of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone (3-AP) (triapine) radiochemotherapy.

SECONDARY OBJECTIVES:

I. Determining acute < 30 day adverse events of 3-AP radiochemotherapy by Common Terminology Criteria for Adverse Events (CTCAE), version 4.

II. Determining the late >= 30 day adverse events of 3-AP radiochemotherapy by CTCAE version 4.

III. Determining post-therapy clinical response by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

IV. Determining the progression-free interval of 3-AP radiochemotherapy. V. Determining peripheral blood methemoglobin proportion before and after 3-AP infusion. (Optional)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cisplatin intravenously (IV) over 90 minutes on days 2, 9, 16, 23, and 30 of radiation therapy. Patients undergo external beam radiation therapy (EBRT) five days a week for 5 weeks with a boost in week 6 followed by 5 sessions of high dose rate (HDR) brachytherapy once or twice weekly beginning in week 4 or up to 2 sessions of low dose rate (LDR) brachytherapy within 3 weeks of completion of EBRT.

ARM II: Patients receive triapine IV over 90-120 minutes on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33 of radiation therapy. Patients also receive cisplatin IV and undergo EBRT and brachytherapy as in Arm I.

In both arms, treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 3, and 6 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Squamous Cell
• Cervical Adenocarcinoma
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• Stage IB2 Cervical Cancer
• Stage II Vaginal Cancer
• Stage IIA1 Cervical Cancer
• Stage IIA2 Cervical Cancer
• Stage IIB Cervical Cancer
• Stage III Vaginal Cancer
• Stage IIIA Cervical Cancer
• Stage IIIB Cervical Cancer
• Stage IVA Cervical Cancer
• Stage IVA Vaginal Cancer
• Uterine Cervical Neoplasms
• Vaginal Adenocarcinoma
• Vaginal Adenosquamous Carcinoma
• Vaginal Neoplasms
• Vaginal Squamous Cell Carcinoma

• NCT number: NCT01835171
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 2013