N-acetylcysteine Given IV With Cisplatin and Paclitaxel in Patients With Ovarian Cancer

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Female

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 include nephro, oto, and nerve toxicities. It may be possible to reduce the toxicities of cisplatin by administering it in conjunction with IV NAC. NAC may reduce cisplatin related nephro, oto, and nerve toxicities without compromising the effectiveness of the chemotherapy against the ovarian cancer cells. It is possible that this combination of drugs may in the future allow ovarian cancer patients to receive the full series of IP cisplatin-paclitaxel chemotherapy, with fewer side effects and improved survival.

It is hypothesized that the proposed treatment of stage III or IV epithelial ovarian cancer with IP cisplatin and IV/IP paclitaxel in conjunction with IV NAC will limit the neurotoxicity, nephrotoxicity and ototoxicity that is associated with cisplatin administration.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Treatments: Acetylcysteine; Albumin-Bound Paclitaxel; Cisplatin; N-monoacetylcystine; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.