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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00030472
• Other study ID #: CDR0000069168
• Secondary ID: GOG-0127R
• Status: Terminated
• Phase: Phase 2
• First received: February 14, 2002
• Last updated: April 10, 2013
• Start date: December 2001

Study information

• Verified date: September 2004
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• pegylated liposomal doxorubicin hydrochloride

Locations

Country	Name	City	State
Norway	Norwegian Radium Hospital	Oslo
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	Tufts - New England Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Fletcher Allen Health Care - Medical Center Campus	Burlington	Vermont
United States	Cooper University Hospital	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas M.D. Anderson CCOP Research Base	Houston	Texas
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Norway, 

References & Publications (1)

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. — View Citation