Cervical Cancer Clinical Trial
Official title:
Evaluation of Intravenously Administered Tirapazamine Plus Cisplatin in 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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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