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

Phase 2
Terminated
Conditions
Cervical Cancer
Registration Number
NCT00030472
Lead Sponsor
Gynecologic Oncology Group
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (17)

Jonsson Comprehensive Cancer Center, UCLA

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Community Hospital of Los Gatos

πŸ‡ΊπŸ‡Έ

Los Gatos, California, United States

MBCCOP - Hawaii

πŸ‡ΊπŸ‡Έ

Honolulu, Hawaii, United States

Holden Comprehensive Cancer Center at University of Iowa

πŸ‡ΊπŸ‡Έ

Iowa City, Iowa, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

πŸ‡ΊπŸ‡Έ

Bethesda, Maryland, United States

Tufts - New England Medical Center

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

Cooper University Hospital

πŸ‡ΊπŸ‡Έ

Camden, New Jersey, United States

Roswell Park Cancer Institute

πŸ‡ΊπŸ‡Έ

Buffalo, New York, United States

State University of New York Health Sciences Center - Stony Brook

πŸ‡ΊπŸ‡Έ

Stony Brook, New York, United States

Lineberger Comprehensive Cancer Center, UNC

πŸ‡ΊπŸ‡Έ

Chapel Hill, North Carolina, United States

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Jonsson Comprehensive Cancer Center, UCLA
πŸ‡ΊπŸ‡ΈLos Angeles, California, United States

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