Topotecan in Treating Women With Persistent or Recurrent Cervical Cancer
Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, cervical squamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the cervix Squamous cell or nonsquamous cell Persistent or recurrent disease Documented disease progression Measurable disease At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan Tumors within a previously irradiated field are considered non-target lesions unless disease progression is documented or a biopsy is obtained to confirm persistent disease at least 90 days after completion of prior radiotherapy Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or nonsquamous cell carcinoma of the cervix Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age 18 and over Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Other Sensory or motor neuropathy ≤ grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following: Monoclonal antibodies Cytokines Small-molecule inhibitors of signal transduction At least 3 weeks since prior biologic or immunologic agents for cervical cancer No concurrent prophylactic growth factors, including filgrastim (G-CSF), sargramostim (GM-CSF), or pegfilgrastim No concurrent prophylactic thrombopoietic agents Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No more than 1 prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy) No prior topotecan Endocrine therapy At least 1 week since prior hormonal therapy for cervical cancer Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics Recovered from prior radiotherapy Surgery Recovered from prior surgery Other At least 3 weeks since other prior therapy for cervical cancer No prior cancer therapy that would preclude study participation
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
- Kaiser Permanente Medical Center - Los Angeles
- Jonsson Comprehensive Cancer Center at UCLA
- Olive View - UCLA Medical Center Foundation
- Helen and Harry Gray Cancer Center at Hartford Hospital
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
- Yale Cancer Center
- Lakeland Regional Cancer Center at Lakeland Regional Medical Center
- Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- University of Chicago Cancer Research Center
- Indiana University Melvin and Bren Simon Cancer Center
- Holden Comprehensive Cancer Center at University of Iowa
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- William Beaumont Hospital - Royal Oak Campus
- University of Mississippi Cancer Clinic
- Regional Cancer Center at Singing River Hospital
- Saint Louis University Cancer Center
- Methodist Estabrook Cancer Center
- Duke Comprehensive Cancer Center
- Charles M. Barrett Cancer Center at University Hospital
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Riverside Methodist Hospital Cancer Care
- Mount Carmel Health - West Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Oklahoma University Cancer Institute
- Cancer Care Associates - Midtown Tulsa
- Women and Infants Hospital of Rhode Island
Arms of the Study
Arm 1
Experimental
Topotecan
Topotecan weekly