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Paclitaxel in Treating Patients With Ovarian Stromal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006227
First received: September 11, 2000
Last updated: March 16, 2016
Last verified: March 2016
  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
Adult Type Ovarian Granulosa Cell Tumor
Ovarian Gynandroblastoma
Ovarian Sertoli-Leydig Cell Tumor
Ovarian Sex Cord Tumor With Annular Tubules
Ovarian Steroid Cell Tumor
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/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 ]

Enrollment: 31
Study Start Date: November 2000
Primary Completion Date: July 2013 (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
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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 Cancer Center
Birmingham, Alabama, United States, 35233
United States, Arizona
Banner Thunderbird Medical Center
Glandale, Arizona, United States, 85306
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
Western Regional CCOP
Phoenix, Arizona, United States, 85006
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85251
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
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Community Hospital of Los Gatos
Los Gatos, California, United States, 95032
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California, United States, 94040
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
United States, Colorado
North Colorado Medical Center
Greeley, Colorado, United States, 80631
McKee Medical Center
Loveland, Colorado, United States, 80539
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 University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States, 46260
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Medical Center of Baton Rouge
Baton Rouge, Louisiana, United States, 70816
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-Einstein Campus
Bronx, New York, United States, 10461
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
Brookview Research Incorporated
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
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
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
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
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Penn State Hershey Cancer Institute-Clinical Trials Office
Hershey, Pennsylvania, United States, 17033-0850
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, Tennessee
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States, 37917
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Wilford Hall Medical Center
Lackland AFB, Texas, United States, 78236
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Washington
MultiCare Auburn Medical Center
Auburn, Washington, United States, 98001
Providence Regional Cancer System-Centralia
Centralia, Washington, United States, 98531
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Saint Clare Hospital
Lakewood, Washington, United States, 98499
Providence - Saint Peter Hospital
Olympia, Washington, United States, 98506-5166
Capital Medical Center
Olympia, Washington, United States, 98507
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States, 98372
MultiCare Allenmore Hospital
Tacoma, Washington, United States, 98405
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States, 98405
Cancer Institutes of Washington PLLC
Yakima, Washington, United States, 98902
United States, West Virginia
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Japan
Tohoku University School of Medicine
Sendai, Aoba-ku, Japan, 980-8574
Sapporo Medical College
Sapporo, Chuo-ku, Japan, 060-8556
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
Kagoshima City Hospital
Kagoshima City, Kagoshima, Japan, 890-8760
Kawasaki Medical School
Okayama-Ken, Kurashiki, Japan, 701-0192
Keio University
Shinjuku-ku, Tokyo, Japan, 160-8582
National Hospital Organization-Kobe Medical Center
Kobe, Japan, 654-0155
Shikoku Cancer Center
Matsuyama, Japan, 791-0280
National Kyushu Cancer Center
Minami-ku, Japan, 811 1395
Jikei University School of Medicine
Minato-ku, Tokyo, Japan, 105-8461
Kinki University
Osaka, Osaka, Japan, 589 8511
Tottori University
Tottori, Japan, 680-8550
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Linda Van Le NRG Oncology
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00006227     History of Changes
Other Study ID Numbers: GOG-0187  NCI-2011-02054  GOG #0187  CDR0000068149  GOG-0187  GOG-0187  U10CA180868  U10CA027469 
Study First Received: September 11, 2000
Last Updated: March 16, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Sertoli-Leydig Cell Tumor
Leydig Cell Tumor
Granulosa Cell Tumor
Sex Cord-Gonadal Stromal Tumors
Neoplasms, Gonadal Tissue
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Testicular Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Endocrine System Diseases
Gonadal Disorders
Testicular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 06, 2016