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Research and Clinical Trials

Title  
GOG 0264: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary
Brief Description  
The main purpose of this study is to determine if giving the drug combination of paclitaxel and carboplatin is as effective as giving bleomycin, etoposide and cisplatin (standard of care) in treating patients with sex cord-stromal tumors of the ovary.
Who may be Eligible  
To qualify for randomization and treatment the following criteria must be met: have histologically confirmed ovarian stromal tumor; have newly diagnosed Stage IIA - IV disease within 8 weeks from surgery or biopsy-proven recurrent disease of any stage and have never received cytotoxic chemotherapy; patients of childbearing potential must have a negative serum pregnancy test and must agree to practice an effective means of birth control; must have performance grade of 0, 1, or 2; have adequate pulmonary function by physical exam and by carbon monoxide diffusion testing; at least 18 years old. Key exclusion criteria: prior cytotoxic chemotherapy or biologics for sex cord-stromal tumors; patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years.
Speciality/Disorder  
Gynecological Cancer
IRB Number  
04-10-03A
Principal Investigator  
Higgins, Robert

For More Information, Contact  Sarah  , Norek
Phone:  (704) 355-1520  Fax:  (704) 355-9897  
Email:  sarah.norek@carolinashealthcare.org
Address:Blumenthal Cancer Center 1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204
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