liposomal doxorubicin in treating patients with persistent or recurrent cancer of the cervix

Conditions: Cervical Cancer

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.

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.

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

Keywords: recurrent cervical cancer stage ivb cervical cancer cervical squamous cell carcinoma