S9717 Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00003369|
Recruitment Status : Completed
First Posted : June 24, 2004
Last Update Posted : June 14, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: cisplatin Drug: tirapazamine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in Cervical Cancer|
|Study Start Date :||August 1998|
|Actual Primary Completion Date :||October 2003|
|Actual Study Completion Date :||July 2004|
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
- overall survival [ Time Frame: 6 months ]From date of registration to date of death due to any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003369
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|Study Chair:||Harriet O. Smith, MD||University of New Mexico Cancer Center|