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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

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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Drug: pegylated liposomal doxorubicin hydrochloride Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Liposomal Doxorubicin (Doxil) in the Treatment of Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
Study Start Date : December 2001
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030472


Locations
Show Show 17 study locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Peter G. Rose, MD MetroHealth Cancer Care Center at MetroHealth Medical Center
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00030472    
Other Study ID Numbers: CDR0000069168
GOG-0127R
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: September 2004
Keywords provided by Gynecologic Oncology Group:
recurrent cervical cancer
stage IVB cervical cancer
cervical squamous cell carcinoma
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action