Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy
N/A
N/A
Female
Ovarian Cancer
Trial Information
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy
OBJECTIVES:
- 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
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times normal
- SGOT no greater than 3 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior invasive malignancy in past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to study lesion
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Frequency of complete clinical response
Safety Issue:
No
Principal Investigator
Linda Van Le, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
Unspecified
Study ID:
CDR0000068149
NCT ID:
NCT00006227
Start Date:
November 2000
Completion Date:
Related Keywords:
- Ovarian Cancer
- ovarian stromal cancer
- Ovarian Neoplasms
Name | Location |
|---|---|
| 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 |
