Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Ovarian Gynandroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006227
• Other study ID #: GOG-0187
• Secondary ID: NCI-2011-02054GO
• Status: Completed
• Phase: Phase 2
• Start date: November 20, 2000
• Est. completion date: July 16, 2016

Study information

• Verified date: February 2020
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 16, 2016
• Est. primary completion date: July 16, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Type Ovarian Granulosa Cell Tumor
• Leydig Cell Tumor
• Neoplasms
• Ovarian Gynandroblastoma
• Ovarian Sertoli-Leydig Cell Tumor
• Ovarian Sex Cord Tumor With Annular Tubules
• Ovarian Steroid Cell Tumor
• Sertoli-Leydig Cell Tumor

Intervention

Drug:
• Paclitaxel
Given IV

Locations

Country	Name	City	State
Japan	Kagoshima City Hospital	Kagoshima City	Kagoshima
Japan	National Hospital Organization-Kobe Medical Center	Kobe
Japan	Shikoku Cancer Center	Matsuyama
Japan	National Kyushu Cancer Center	Minami-ku
Japan	Jikei University School of Medicine	Minato-ku, Tokyo
Japan	Iwate Medical University School of Medicine	Morioka	Iwate
Japan	Kawasaki Medical School	Okayama-Ken	Kurashiki
Japan	Kindai University	Osaka, Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical College	Sapporo	Chuo-ku
Japan	Tohoku University School of Medicine	Sendai	Aoba-ku
Japan	Keio University	Shinjuku-ku	Tokyo
Japan	Tottori University	Tottori
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Lehigh Valley Hospital-Cedar Crest	Allentown	Pennsylvania
United States	MultiCare Auburn Medical Center	Auburn	Washington
United States	Rush - Copley Medical Center	Aurora	Illinois
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Medical Center of Baton Rouge	Baton Rouge	Louisiana
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	Montefiore Medical Center - Moses Campus	Bronx	New York
United States	Montefiore Medical Center-Einstein Campus	Bronx	New York
United States	State University of New York Downstate Medical Center	Brooklyn	New York
United States	Cooper Hospital University Medical Center	Camden	New Jersey
United States	Aultman Health Foundation	Canton	Ohio
United States	Providence Regional Cancer System-Centralia	Centralia	Washington
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Carolinas Medical Center/Levine Cancer Institute	Charlotte	North Carolina
United States	University of Virginia Cancer Center	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati/Barrett Cancer Center	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic Cancer Center/Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	South Carolina Oncology Associates PA	Columbia	South Carolina
United States	Mount Carmel Health Center West	Columbus	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Saint Francis Hospital	Federal Way	Washington
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
United States	Banner Thunderbird Medical Center	Glendale	Arizona
United States	North Colorado Medical Center	Greeley	Colorado
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Sudarshan K Sharma MD Limted-Gynecologic Oncology	Hinsdale	Illinois
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Saint Vincent Hospital and Health Care Center	Indianapolis	Indiana
United States	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Joliet Oncology-Hematology Associates Limited	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Keesler Medical Center	Keesler Air Force Base	Mississippi
United States	Kettering Medical Center	Kettering	Ohio
United States	Southeast Gynecologic Oncology Associates	Knoxville	Tennessee
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Saint Clare Hospital	Lakewood	Washington
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
United States	Beebe Medical Center	Lewes	Delaware
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Long Beach Memorial Medical Center-Todd Cancer Institute	Long Beach	California
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	Community Hospital of Los Gatos	Los Gatos	California
United States	Norton Hospital Pavilion and Medical Campus	Louisville	Kentucky
United States	McKee Medical Center	Loveland	Colorado
United States	Hillcrest Hospital Cancer Center	Mayfield Heights	Ohio
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Lake University Ireland Cancer Center	Mentor	Ohio
United States	Franciscan Saint Anthony Health-Michigan City	Michigan City	Indiana
United States	West Virginia University Healthcare	Morgantown	West Virginia
United States	Palo Alto Medical Foundation-Gynecologic Oncology	Mountain View	California
United States	Jersey Shore Medical Center	Neptune	New Jersey
United States	The Hospital of Central Connecticut	New Britain	Connecticut
United States	Christiana Care Health System-Christiana Hospital	Newark	Delaware
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Capital Medical Center	Olympia	Washington
United States	Providence - Saint Peter Hospital	Olympia	Washington
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Banner-University Medical Center Phoenix	Phoenix	Arizona
United States	Western Regional CCOP	Phoenix	Arizona
United States	MultiCare Good Samaritan Hospital	Puyallup	Washington
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	UCSF Medical Center-Mount Zion	San Francisco	California
United States	Memorial University Medical Center	Savannah	Georgia
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	MultiCare Allenmore Hospital	Tacoma	Washington
United States	Northwest NCI Community Oncology Research Program	Tacoma	Washington
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma
United States	Brookview Research Incorporated	Winston-Salem	North Carolina
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina
United States	Novant Health Oncology Specialists	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 5 years
Secondary	Progression-free Survival	Duration of progression free survival (median) (months)	The period from study entry until disease progression, death or date of last contact
Secondary	Overall Survival	Duration of overall survival (median) (months)	The observed length of life from entry into the study to death or the date of last contact