Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006227
First received: September 11, 2000
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.


Condition Intervention Phase
Ovarian Stromal Cancer
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Frequency of complete clinical response, assessed using GOG RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of progression-free survival [ Time Frame: The period from study entry until disease progression, death or date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: The observed length of life from entry into the study to death or the date of last contact, assessed up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: November 2000
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (paclitaxel)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Detailed Description:

OBJECTIVES:

I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma.

II. To evaluate the value of inhibin for predicting response.

OUTLINE:

Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed ovarian stromal cancer not amenable to surgery

    • Granulosa cell tumor
    • Granulosa cell theca cell tumor
    • Sertoli-Leydig cell tumor (androblastoma)
    • Gynandroblastoma
    • Unclassified sex cord stromal tumor
    • Sex cord tumor with annular tubules
    • Steroid (lipid) cell tumor
  • Recurrent disease after no more than 1 prior chemotherapy regimen
  • Measurable disease

    • At least 1 cm in diameter
  • Performance status - GOG 0-2
  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Creatinine no greater than 2.0 mg/dL
  • Not pregnant
  • Negative pregnancy test
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Fertile patients must use effective contraception
  • No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer
  • No prior radiotherapy to study lesion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006227

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Long Beach Memorial Medical Center-Todd Cancer Institute
Long Beach, California, United States, 90806
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
UCSF-Mount Zion
San Francisco, California, United States, 94115
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
Hawaii Minority Based CCOP
Honolulu, Hawaii, United States, 96813
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Norton Health Care Pavilion - Downtown
Louisville, Kentucky, United States, 40202
United States, Maryland
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Keesler Medical Center
Kessler AFB, Mississippi, United States, 39534
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Jersey Shore Medical Center
Neptune, New Jersey, United States, 07753
United States, New York
Montefiore Medical Center-Weiler Division
Bronx, New York, United States, 10461
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44710
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Kettering Medical Center
Kettering, Ohio, United States, 45429
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates-Yale
Tulsa, Oklahoma, United States, 74136-1929
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
South Carolina Oncology Associates PA
Columbia, South Carolina, United States, 29210
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Cancer Institutes of Washington PLLC
Yakima, Washington, United States, 98902
Japan
Tohoku University School of Medicine
Sendai, Aoba-ku, Japan, 980-8574
Kure National Hospital
Kure, Hiroshima, Japan, 737
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Iwate Medical University School of Medicine
Morioka, Iwate, Japan, 020-8505
Keio University
Shinjuku-ku, Tokyo, Japan, 160-8582
Kagoshima City Hospital
Kagoshima City, Kagoshima, Japan, 892-8580
Shikoku Cancer Center
Matsuyama, Japan, 791-0280
National Kyushu Cancer Center
Minami-ku, Japan, 811 1395
Kinki University
Osaka, Osaka, Japan, 589 8511
Tottori University
Tottori, Japan, 680-8550
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Linda Van Le Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00006227     History of Changes
Other Study ID Numbers: GOG-0187, NCI-2011-02054, CDR0000068149, GOG-0187, GOG-0187, U10CA027469
Study First Received: September 11, 2000
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014