Status:
COMPLETED
Cisplatin Induction With Paclitaxel Consolidation for Stage III-IV Epithelial Ovarian and Primary Peritoneal Cancer
Lead Sponsor:
John P. Fruehauf
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Clinically, there has been extensive experience with topotecan and cisplatin. Recently, several investigators have evaluated the combination of paclitaxel, cisplatin and topotecan. As expected, myelos...
Detailed Description
Malignant neoplasms of the ovary are the cause of more deaths than any other gynecologic cancer. Approximately 26,500 new cases are diagnosed each year in the United States, and about 14,500 deaths oc...
Eligibility Criteria
Inclusion
- Eligible Subjects:
- Subjects with a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma, stage III or IV, as outlined above. All subjects must have appropriate surgery for ovarian carcinoma with appropriate tissue for histologic evaluation and evaluated by the EDR assay.
- Eligible cell types include:
- Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor
- Adequate bone marrow, renal, and hepatic function as defined by WBC3000cells/mcl, platelets 100,000/mcl, serum creatinine 2mg/dcl, bilirubin 1.5times normal, and SGOT 3 times normal.
- Subjects with GOG Performance Status of 0, 1, or 2.
- Subjects must have a complete history and physical examination done by the investigators of this study. Also, CBC with differential, electrolytes, serum creatinine, liver function tests and CA 125 must be done 14 days prior to registration.
- Subjects must be informed of the investigational nature of this study and must provide informed consent in accordance with institutional and federal guidelines.
- All subjects must have histologic slides available for pathology review.
- Subjects must be entered within six weeks of surgery.
- Ineligible Subjects:
- Subjects with epithelial ovarian carcinoma of low malignant potential.
- Subjects who have received prior radiotherapy or chemotherapy.
- Subjects with septicemia, severe infection, or acute hepatitis.
- Subjects with severe gastrointestinal bleeding.
- Subjects with a GOG Performance Status of 3 or 4.
- Subjects with other invasive malignancies, with the exception of non-melanoma skin cancer, who had or have any evidence of other cancer within the last 5 years or whose previous cancer treatment contradicts this protocol therapy.
- Subjects who are pregnant will be excluded.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00314678
Start Date
September 1 2005
End Date
April 1 2007
Last Update
December 8 2016
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868