Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix

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