Overview

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

Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Tirapazamine
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous or adenosquamous carcinoma of
the cervix that is metastatic, recurrent, or refractory Any stage disease treated with
prior radical surgery and/or definitive radiotherapy that has locally recurred and is no
longer amenable to surgery or radiotherapy OR Metastatic disease that is not amenable to
surgery or radiation therapy Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Not specified Renal: Creatinine no greater than 1.5 times upper limit of normal
Other: No history of allergic reaction to mannitol Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception during and for 3 months
after study No other prior malignancy except: Adequately treated basal cell or squamous
cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer from which
the patient is currently in complete remission Any other cancer from which the patient has
been disease free for 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factor therapy
Chemotherapy: Prior chemotherapy (hydroxyurea, fluorouracil, metronidazole, cisplatin, or
other platinum agent) allowed as a radiosensitizing agent only No other concurrent
chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Prior radiotherapy allowed to less than 30% of the bone marrow only Recovered from toxic
effects No concurrent radiotherapy Surgery: See Disease Characteristics Prior surgery
allowed Recovered from effects of prior surgery Other: No prior systemic therapy for this
disease