N-acetylcysteine Given IV With Cisplatin and Paclitaxel in Patients With Ovarian Cancer
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.
Timeline
- Start
- 2010-06
- Primary completion
- 2014-12
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | N-acetylcysteine | Small molecule | 150 mg/kg | Intravenous |
| Subject | N-acetylcysteine | Small molecule | 300 mg/kg | Intravenous |
| Subject | N-acetylcysteine | Small molecule | 600 mg/kg | Intravenous |
| Subject | N-acetylcysteine | Small molecule | 800 mg/kg | Intravenous |
| Subject | N-acetylcysteine | Small molecule | 1000 mg/kg | Intravenous |
| Subject | N-acetylcysteine | Small molecule | 1200 mg/kg | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Other |
| Background | Paclitaxel | Small molecule | 60 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 135 mg/m2 | Intravenous |