NCT00003369

S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer

Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	cisplatin	75 mg/m2 IV as a one-hour infusion after tirapazamine on Day 1 of each 21-day cycle
DRUG	tirapazamine	260 mg/m2 over two hours prior to cisplatin on Day 1 of each 21-day cycle

Timeline

• Start date: 1998-08-01
• Primary completion: 2003-10-01
• Completion: 2004-07-01
• First posted: 2004-06-24
• Last updated: 2012-06-14

Locations

85 sites across 1 country: United States