Paclitaxel in Treating Patients With Ovarian Stromal Cancer

Completed · Phase 2

Conditions studied: Adult Type Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor, Ovarian Sex Cord Tumor With Annular Tubules, Ovarian Steroid Cell Tumor

In brief

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.

Key facts

Study ID

NCT00006227

Run by

Gynecologic Oncology Group

People needed

31

Starts

2000-11-20

Expected to finish

2016-07-16

Last updated by the study team

2020-03-05

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Banner Thunderbird Medical Center — Glendale, Arizona, United States
• Banner-University Medical Center Phoenix — Phoenix, Arizona, United States
• Western Regional CCOP — Phoenix, Arizona, United States
• Scottsdale Healthcare — Scottsdale, Arizona, 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
• Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Memorial University Medical Center — Savannah, Georgia, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Sudarshan K Sharma MD Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• Joliet Oncology-Hematology Associates Limited — Joliet, 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 Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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