Cervical Cancer
Conditions
Keywords
recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness liposomal doxorubicin in treating patients who have persistent or recurrent cancer of the cervix.
Detailed description
OBJECTIVES: * Determine the antitumor activity of doxorubicin HCl liposome in patients with persistent or recurrent squamous cell carcinoma of the cervix. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
Norway, United States