- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030472
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oslo, Norway, N-0310
- Norwegian Radium Hospital
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California
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Los Angeles, California, United States, 90095-1740
- Jonsson Comprehensive Cancer Center, UCLA
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Los Gatos, California, United States, 95032
- Community Hospital of Los Gatos
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Hawaii
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Honolulu, Hawaii, United States, 96813
- MBCCOP - Hawaii
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Iowa
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Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Maryland
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Massachusetts
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Boston, Massachusetts, United States, 02111
- TUFTS - New England Medical Center
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New Jersey
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Camden, New Jersey, United States, 08103-1489
- Cooper University Hospital
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Stony Brook, New York, United States, 11794-8091
- State University of New York Health Sciences Center - Stony Brook
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Ohio
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Cincinnati, Ohio, United States, 45267-0526
- Charles M. Barrett Cancer Center at University Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Pennsylvania
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Abington, Pennsylvania, United States, 19001-3788
- Abington Memorial Hospital
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Texas
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Galveston, Texas, United States, 77555-0587
- University of Texas Medical Branch
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Houston, Texas, United States, 77030-4009
- University of Texas M.D. Anderson CCOP Research Base
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Vermont
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Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care - Medical Center Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Peter G. Rose, MD, MetroHealth Cancer Care Center at MetroHealth Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CDR0000069168
- GOG-0127R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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