S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of tirapazamine plus cisplatin in treating patients who have metastatic, recurrent, or refractory cervical cancer.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer|
- overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]From date of registration to date of death due to any cause
|Study Start Date:||August 1998|
|Study Completion Date:||July 2004|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
tirapazamine and cisplatin given Day 1 of each 21-day treatment cycle
75 mg/m2 IV as a one-hour infusion after tirapazamine on Day 1 of each 21-day cycle
Other Name: platinolDrug: tirapazamine
260 mg/m2 over two hours prior to cisplatin on Day 1 of each 21-day cycle
OBJECTIVES: I. Evaluate the survival of patients with metastatic or recurrent epithelial squamous or adenosquamous carcinoma of the cervix when treated with intravenous tirapazamine plus intravenous cisplatin. II. Evaluate the unconfirmed complete and partial response rates of these patients, as well as, the nature and degree of toxicity associated with this regimen in this patient population.
OUTLINE: Patients receive tirapazamine intravenously over 2 hours and then, following a 1 hour rest, receive cisplatin intravenously over 1 hour. Courses are repeated every 21 days. Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease progression. All patients are followed every 6 months for 2 years, then annually thereafter until death.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.