Status:
WITHDRAWN
N-acetylcysteine Given IV With Cisplatin and Paclitaxel in Patients With Ovarian Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Conditions:
Ovarian Carcinoma, Stage 3 or 4
Epithelial Ovarian Carcinoma
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
Brief Summary
RATIONAL FOR STUDYING IV NAC AS POTENTIAL CHEMOPROTECTANT: Cisplatin has shown efficacy in the treatment of subjects with epithelial ovarian cancer. Systemic toxicities associated with cisplatin incl...
Detailed Description
OBJECTIVES: PRIMARY: To determine the Maximum Tolerated Dose (MTD) and assess the toxicity of IV NAC in conjunction with IP cisplatin and IV/IP paclitaxel in subjects with stage 3 or 4 epithelial ov...
Eligibility Criteria
Inclusion
- Signed written informed consent in accordance with institutional guidelines
- Histologically confirmed diagnosis of stage 3 or 4 epithelial ovarian or primary peritoneal carcinoma
- Have had debulking surgery with optimal tumor cytoreduction
- Standard treatment offered for ovarian cancer including systemic or intraperitoneal cisplatin with systemic taxane-based chemotherapy
- Age ≥ 18 years to ≤ 75 years
- Laboratory testing within 14 days of registration:
- White blood cell count ≥ 2.5 x 103/mm3
- Absolute granulocyte count ≥ 1.2 x 103/mm3
- Platelets ≥ 100 x 103/mm3
- Creatinine \< 1.8
- Bilirubin \< 2.0
- Serum glutamate oxaloacetate transaminase (SGOT)/Serum glutamate pyruvate transaminase (SGPT) \< 2.5 x institutional upper limits of normal
- Performance status must be Eastern Cooperative Oncology Group (ECOG) \< 2 (Karnofsky ≥ 50)
- Life expectancy of ≥ 60 days from the date of registration
Exclusion
- Pregnant, positive beta human chorionic gonadotropin (hCG), or lactating
- History of clinically significant reactive airway disease
- Active significant cardiac disease as evidenced by New York Heart Association Classification for chronic heart failure (CHF), Class III or IV
- Uncontrolled (over the last 30 days) clinically significant confounding medical conditions
- Allergies or other contraindications to IP cisplatin, IV Taxol, or IV NAC.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01138137
Start Date
June 1 2010
End Date
December 1 2014
Last Update
April 21 2017
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239