A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix

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