Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma (SCC) of the cervix Persistent or recurrent progressive disease Must have failed local therapeutic measures and considered incurable 1 prior chemotherapeutic regimen for SCC of the cervix required Initial treatment may include high-dose therapy, consolidation, or extended therapy Ineligible for a higher priority GOG protocol At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Target lesion may not be within a previously irradiated field PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1,500/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No congestive heart failure No unstable angina No myocardial infarction or new cardiac arrhythmia in the past 6 months Other: No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: 1 prior noncytotoxic biologic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic cytostatic regimen for recurrent or persistent disease management) At least 3 weeks since prior biologic or immunologic therapy for SCC of the cervix Chemotherapy: See Disease Characteristics No prior doxorubicin or doxorubicin HCl liposome 1 prior noncytotoxic cytostatic regimen allowed for recurrent or persistent disease (provided patient has not received a noncytotoxic biologic regimen for recurrent or persistent disease management) No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens Recovered from prior chemotherapy Endocrine therapy: At least 1 week since prior hormonal therapy for SCC of the cervix 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 SCC of the cervix No prior anticancer treatment that precludes study
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA
- Community Hospital of Los Gatos
- MBCCOP - Hawaii
- Holden Comprehensive Cancer Center at University of Iowa
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
- Tufts - New England Medical Center
- Cooper University Hospital
- Roswell Park Cancer Institute
- State University of New York Health Sciences Center - Stony Brook
- Lineberger Comprehensive Cancer Center, UNC
- Charles M. Barrett Cancer Center at University Hospital
- Cleveland Clinic Taussig Cancer Center
- Abington Memorial Hospital
- University of Texas Medical Branch
- University of Texas M.D. Anderson CCOP Research Base
- Fletcher Allen Health Care - Medical Center Campus
- Norwegian Radium Hospital