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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin

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