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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00030472
Enrollment
Unknown
Registered
2003-01-27
Start date
2001-12-31
Completion date
Unknown
Last updated
2013-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma

Brief 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.

Detailed 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.

Interventions

DRUGpegylated liposomal doxorubicin hydrochloride

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Gynecologic Oncology Group
Lead SponsorNETWORK

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Countries

Norway, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026