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Adult Type Ovarian Granulosa Cell TumorPhase 2NCT00006227

Paclitaxel in Treating Patients With Ovarian Stromal Cancer

A Phase 2 study testing Paclitaxel in people with Adult Type Ovarian Granulosa Cell Tumor and Ovarian Gynandroblastoma, run by Gynecologic Oncology Group at 98 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
98 sitesin 2 countries
Study dates
20 Nov 2000to 16 Jul 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

98 sites in 2 countries.

98 sites in 2 countries

United States85 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • State University of New York Downstate Medical Center

    Brooklyn, New York, 11203

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • South Carolina Oncology Associates PA

    Columbia, South Carolina, 29210

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Banner Thunderbird Medical Center

    Glendale, Arizona, 85306

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Sudarshan K Sharma MD Limted-Gynecologic Oncology

    Hinsdale, Illinois, 60521

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Saint Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Keesler Medical Center

    Keesler Air Force Base, Mississippi, 39534

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Southeast Gynecologic Oncology Associates

    Knoxville, Tennessee, 37917

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Long Beach Memorial Medical Center-Todd Cancer Institute

    Long Beach, California, 90806

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, 94040

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Providence - Saint Peter Hospital

    Olympia, Washington, 98506-5166

  • Capital Medical Center

    Olympia, Washington, 98507

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Western Regional CCOP

    Phoenix, Arizona, 85006

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • UCSF Medical Center-Mount Zion

    San Francisco, California, 94115

  • Memorial University Medical Center

    Savannah, Georgia, 31404

  • Scottsdale Healthcare

    Scottsdale, Arizona, 85251

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • MultiCare Allenmore Hospital

    Tacoma, Washington, 98405

  • Northwest NCI Community Oncology Research Program

    Tacoma, Washington, 98405

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467-2490

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Brookview Research Incorporated

    Winston-Salem, North Carolina, 27103

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan13 sites

  • Kagoshima City Hospital

    Kagoshima, Kagoshima-ken, 890-8760

  • National Hospital Organization-Kobe Medical Center

    Kobe, 654-0155

  • Shikoku Cancer Center

    Matsuyama, 791-0280

  • National Kyushu Cancer Center

    Minamiku, 811 1395

  • Jikei University School of Medicine

    Minato-ku, Tokyo, 105-8461

  • Iwate Medical University School of Medicine

    Morioka, Iwate, 020-8505

  • Kawasaki Medical School

    Okayama-Ken, Kurashiki, 701-0192

  • Kindai University

    Osaka, Osaka, 589 8511

  • Sapporo Medical College

    Sapporo, Chuo-ku, 060-8556

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University School of Medicine

    Sendai, Aoba-ku, 980-8574

  • Keio University

    Shinjuku-ku, Tokyo, 160-8582

  • Tottori University

    Tottori, 680-8550

Other trials in Japan

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Paclitaxel
Medical subject headings
Ovarian gynandroblastoma, Sertoli-Leydig Cell Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00006227
Study groupRoleWhat they receive
Treatment (paclitaxel)ExperimentalPatients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probability of Complete Clinical Response

    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

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Progression-free Survival

    Duration of progression free survival (median) (months)

    Measured: The period from study entry until disease progression, death or date of last contact

  2. Overall Survival

    Duration of overall survival (median) (months)

    Measured: The observed length of life from entry into the study to death or the date of last contact

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start20 Nov 2000
  3. Primary completion16 Jul 2016
  4. Study completion16 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006227
Sponsor's protocol ID
GOG-0187
Other IDs
NCI-2011-02054, GOG #0187, CDR0000068149, GOG-0187, GOG-0187, GOG-0187, U10CA180868, U10CA027469
Status last verified
Feb 2020
First submitted
11 Sep 2000
Last updated
5 Mar 2020

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel in people with Adult Type Ovarian Granulosa Cell Tumor and Ovarian Gynandroblastoma, run by Gynecologic Oncology Group at 98 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probability of Complete Clinical Response (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006227.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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