Paclitaxel in Treating Patients With Ovarian Stromal Cancer

February 18, 2020 updated by: Gynecologic Oncology Group

Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY 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 intravenously (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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kobe, Japan, 654-0155
        • National Hospital Organization-Kobe Medical Center
      • Matsuyama, Japan, 791-0280
        • Shikoku Cancer Center
      • Minami-ku, Japan, 811 1395
        • National Kyushu Cancer Center
      • Minato-ku, Tokyo, Japan, 105-8461
        • Jikei University School of Medicine
      • Osaka, Osaka, Japan, 589 8511
        • Kindai University
      • Tottori, Japan, 680-8550
        • Tottori University
    • Aoba-ku
      • Sendai, Aoba-ku, Japan, 980-8574
        • Tohoku University School of Medicine
    • Chuo-ku
      • Sapporo, Chuo-ku, Japan, 060-8556
        • Sapporo Medical College
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Iwate Medical University School of Medicine
    • Kagoshima
      • Kagoshima City, Kagoshima, Japan, 890-8760
        • Kagoshima City Hospital
    • Kurashiki
      • Okayama-Ken, Kurashiki, Japan, 701-0192
        • Kawasaki Medical School
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Banner Thunderbird Medical Center
      • Phoenix, Arizona, United States, 85006
        • Banner-University Medical Center Phoenix
      • Phoenix, Arizona, United States, 85006
        • Western Regional CCOP
      • Scottsdale, Arizona, United States, 85251
        • Scottsdale Healthcare
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center-Todd Cancer Institute
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Los Gatos, California, United States, 95032
        • Community Hospital of Los Gatos
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Orange, California, United States, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • San Francisco, California, United States, 94115
        • UCSF Medical Center-Mount Zion
    • Colorado
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial University Medical Center
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Rush - Copley Medical Center
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Hinsdale, Illinois, United States, 60521
        • Sudarshan K Sharma MD Limted-Gynecologic Oncology
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates Limited
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University/Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Care Center
      • Michigan City, Indiana, United States, 46360
        • Franciscan Saint Anthony Health-Michigan City
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Norton Hospital Pavilion and Medical Campus
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, United States, 70816
        • Medical Center of Baton Rouge
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Union Hospital of Cecil County
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Keesler Air Force Base, Mississippi, United States, 39534
        • Keesler Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Women's Cancer Center of Nevada
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Einstein Campus
      • Bronx, New York, United States, 10467-2490
        • Montefiore Medical Center - Moses Campus
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Oncology Specialists
      • Winston-Salem, North Carolina, United States, 27103
        • Brookview Research Incorporated
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati/Barrett Cancer Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mentor, Ohio, United States, 44060
        • Lake University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, United States, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates PA
    • Tennessee
      • Knoxville, Tennessee, United States, 37917
        • Southeast Gynecologic Oncology Associates
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center
    • Texas
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
      • Lackland Air Force Base, Texas, United States, 78236
        • Wilford Hall Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Olympia, Washington, United States, 98506-5166
        • Providence - Saint Peter Hospital
      • Olympia, Washington, United States, 98507
        • Capital Medical Center
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Tacoma, Washington, United States, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • Northwest NCI Community Oncology Research Program
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor [androblastoma], steroid [lipid] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules)
  • Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen
  • Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • White blood count equal to or greater than 3000/mcl
  • Granulocyte count equal to or greater than 1500/mcl
  • Platelet count equal to or greater than 100,000/mcl
  • Creatinine equal to or less than 2.0 mg%
  • Bilirubin less than or equal to 1.5 times normal
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal
  • Patients with a GOG performance grade of 0, 1 or 2
  • Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
  • Patients who have met the pre-entry requirements as specified
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

  • Patients with GOG performance grade of 3 or 4
  • Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
  • Patients having received more than one prior chemotherapy regimen
  • Patients amenable to cure by surgery
  • Patients with prior radiation except for those whose recurrent disease is outside the radiation port

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probability of Complete Clinical Response
Time Frame: Up to 5 years
The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: The period from study entry until disease progression, death or date of last contact
Duration of progression free survival (median) (months)
The period from study entry until disease progression, death or date of last contact
Overall Survival
Time Frame: The observed length of life from entry into the study to death or the date of last contact
Duration of overall survival (median) (months)
The observed length of life from entry into the study to death or the date of last contact

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Linda Van Le, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2000

Primary Completion (Actual)

July 16, 2016

Study Completion (Actual)

July 16, 2016

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0187 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • U10CA027469 (U.S. NIH Grant/Contract)
  • NCI-2011-02054 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • GOG #0187
  • CDR0000068149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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