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.

Condition	Treatment or Intervention	Phase
recurrent cervical cancer stage IVB cervical cancer cervical squamous cell carcinoma	Drug: doxorubicin HCl liposome  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Genders Eligible for Study:  Both

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

California
      Community Hospital of Los Gatos, Los Gatos,  California,  95032,  United States
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States
Massachusetts
      Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States
New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11794-8091,  United States
North Carolina
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0526,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States
Texas
      University of Texas M.D. Anderson CCOP Research Base, Houston,  Texas,  77030-4009,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States
Vermont
      Fletcher Allen Health Care - Medical Center Campus, Burlington,  Vermont,  05401,  United States
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway

Study chairs or principal investigators

Peter Graham Rose, MD,  Study Chair,  MetroHealth Medical Center   

Study ID Numbers:  CDR0000069168; GOG-0127R
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  February 14, 2002
ClinicalTrials.gov Identifier:  NCT00030472
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08