NCT00335998View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

October 31, 2008

Conditions
Recurrent Cervical CancerRecurrent Ovarian Epithelial CancerRecurrent Vaginal CancerRecurrent Vulvar CancerStage III Vaginal CancerStage IIIA Cervical CancerStage IIIA Ovarian Epithelial CancerStage IIIA Vulvar CancerStage IIIB Cervical CancerStage IIIB Ovarian Epithelial CancerStage IIIB Vulvar CancerStage IIIC Ovarian Epithelial CancerStage IIIC Vulvar CancerStage IV Ovarian Epithelial CancerStage IVA Cervical CancerStage IVA Vaginal CancerStage IVB Cervical CancerStage 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

Trial Locations (1)

44106

Case Western Reserve University, Cleveland

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00335998 - 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 | Biotech Hunter | Biotech Hunter