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

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pegylated liposomal doxorubicin hydrochloride
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center, UCLA
  • Community Hospital of Los Gatos
  • MBCCOP - Hawaii
  • Holden Comprehensive Cancer Center at University of Iowa
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Tufts - New England Medical Center
  • Cooper University Hospital
  • Roswell Park Cancer Institute
  • State University of New York Health Sciences Center - Stony Brook
  • Lineberger Comprehensive Cancer Center, UNC
  • Charles M. Barrett Cancer Center at University Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Abington Memorial Hospital
  • University of Texas Medical Branch
  • University of Texas M.D. Anderson CCOP Research Base
  • Fletcher Allen Health Care - Medical Center Campus
  • Norwegian Radium Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
April 10, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030472
Brief Title
Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Official Title
A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
September 2004
Overall Recruitment Status
Terminated
Study Start Date
December 2001 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter G. Rose, MD
Organizational Affiliation
MetroHealth Cancer Care Center at MetroHealth Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1740
Country
United States
Facility Name
Community Hospital of Los Gatos
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1489
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8091
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0526
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3788
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0587
Country
United States
Facility Name
University of Texas M.D. Anderson CCOP Research Base
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Fletcher Allen Health Care - Medical Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
16478630
Citation
Rose PG, Blessing JA, Lele S, Abulafia O. Evaluation of pegylated liposomal doxorubicin (Doxil) as second-line chemotherapy of squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Aug;102(2):210-3. doi: 10.1016/j.ygyno.2005.11.048. Epub 2006 Feb 14.
Results Reference
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Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix

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