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

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: pegylated liposomal doxorubicin hydrochloride

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00030472

GOG-0127R

CDR0000069168

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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