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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030472
Recruitment Status : Terminated
First Posted : January 27, 2003
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE February 14, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date April 11, 2013
Study Start Date  ICMJE December 2001
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liposomal Doxorubicin in Treating Patients With Persistent or Recurrent Cancer of the Cervix
Official Title  ICMJE A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE Drug: pegylated liposomal doxorubicin hydrochloride
Study Arms  ICMJE Not Provided
Publications * 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. Epub 2006 Feb 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00030472
Other Study ID Numbers  ICMJE CDR0000069168
GOG-0127R
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Peter G. Rose, MD MetroHealth Cancer Care Center at MetroHealth Medical Center
PRS Account Gynecologic Oncology Group
Verification Date September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP