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


Phase 2
N/A
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

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 ServicesWilmington, Delaware  19899
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Rush University Medical CenterChicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
SUNY Downstate Medical CenterBrooklyn, New York  11203
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Todd Cancer Institute at Long Beach Memorial Medical CenterLong Beach, California  90801
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Palo Alto Medical FoundationPalo Alto, California  94301
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Duke Cancer InstituteDurham, North Carolina  27710
Gynecologic OncologyHinsdale, Illinois  60521
Louisville Oncology at Norton Cancer Institute - LouisvilleLouisville, Kentucky  40202
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
South Carolina Oncology Associates, PAColumbia, South Carolina  29210