Phase I Study of Intravenous Triapine (IND # 68338) in Combination With Pelvic Radiation Therapy With or Without Weekly Intravenous Cisplatin Chemotherapy for Locally Advanced Cervical, Vaginal, or Pelvic Gynecologic Malignancies

Summary

Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 3-AP may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. 3-AP and cisplatin may make tumor cells more sensitive to radiation therapy. Giving 3-AP and external-beam radiation therapy together with cisplatin may kill more tumor cells. This phase I trial is studying the side effects and best dose of 3-AP when given together with external-beam radiation therapy with or without cisplatin in treating patients with gynecologic cancer

Conditions

• Recurrent Cervical Cancer
• Recurrent Ovarian Epithelial Cancer
• Recurrent Vaginal Cancer
• Recurrent Vulvar Cancer
• Stage III Vaginal Cancer
• Stage IIIA Cervical Cancer
• Stage IIIA Ovarian Epithelial Cancer
• Stage IIIA Vulvar Cancer
• Stage IIIB Cervical Cancer
• Stage IIIB Ovarian Epithelial Cancer
• Stage IIIB Vulvar Cancer
• Stage IIIC Ovarian Epithelial Cancer
• Stage IIIC Vulvar Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IVA Cervical Cancer
• Stage IVA Vaginal Cancer
• Stage IVB Cervical Cancer
• Stage IVB Vaginal Cancer

Interventions

DRUG

triapine

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

RADIATION

external beam radiation therapy

Undergo external beam radiation therapy

RADIATION

brachytherapy

Undergo intracavitary or interstitial brachytherapy

DRUG

cisplatin

Given IV

OTHER

pharmacological study

Correlative studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Charles Kunos · Case Western Reserve University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-31

Primary Completion

2008-10-31

Countries

• United States

Study Locations