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

Withdrawn before enrolling · Phase 1

Conditions studied: Ovarian Carcinoma, Stage 3 or 4, Epithelial Ovarian Carcinoma, Primary Peritoneal Carcinoma

In brief

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.

Key facts

Study ID

NCT01138137

Run by

OHSU Knight Cancer Institute

People needed

0

Starts

2010-06-01

Expected to finish

2014-12-01

Last updated by the study team

2017-04-21

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.