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

Phase 2
Open (Enrolling)
Ovarian Cancer

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Trial Information

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


- Determine the clinical response to paclitaxel in patients with ovarian stromal cancer.

- Determine toxicity of this drug in these patients.

- Determine the value of inhibin for predicting response in these patients when treated
with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment
(yes vs no).

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.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.

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



- Not specified

Performance status:

- GOG 0-2

Life expectancy:

- Not specified


- 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

- Fertile patients must use effective contraception

- No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer


Biologic therapy:

- Not specified


- See Disease Characteristics

Endocrine therapy:

- Not specified


- No prior radiotherapy to study lesion


- See Disease Characteristics

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of complete clinical response

Safety Issue:


Principal Investigator

Linda Van Le, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center



Study ID:




Start Date:

November 2000

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • ovarian stromal cancer
  • Ovarian Neoplasms



CCOP - Christiana Care Health Services Wilmington, Delaware  19899
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
Aultman Cancer Center at Aultman Hospital Canton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44109
Rush University Medical Center Chicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
SUNY Downstate Medical Center Brooklyn, New York  11203
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093
University of Mississippi Cancer Clinic Jackson, Mississippi  39216-4505
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
University of Virginia Cancer Center Charlottesville, Virginia  22908
Todd Cancer Institute at Long Beach Memorial Medical Center Long Beach, California  90801
Cleveland Clinic Cancer Center at Fairview Hospital Cleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest Hospital Mayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis Campus Tulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial Hospital Abington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Palo Alto Medical Foundation Palo Alto, California  94301
UAB Comprehensive Cancer Center Birmingham, Alabama  35294
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Fox Chase Cancer Center CCOP Research Base Philadelphia, Pennsylvania  19140
Union Hospital of Cecil County Elkton MD, Maryland  21921
Duke Cancer Institute Durham, North Carolina  27710
Gynecologic Oncology Hinsdale, Illinois  60521
Louisville Oncology at Norton Cancer Institute - Louisville Louisville, Kentucky  40202
Women's Cancer Center - La Canada Las Vegas, Nevada  89169
South Carolina Oncology Associates, PA Columbia, South Carolina  29210