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Phase I Dose Escalation Study of N-acetylcysteine (NAC) Administered Intravenously (IV) in Conjunction With Intraperitoneal (IP) Administered Cisplatin and IV/IP Paclitaxel in Patients With Stage III or IV Ovarian Cancer

This study is currently Recruiting

September 2011 By OHSU Knight Cancer Institute

First Recieved on June 3, 2010

Last Updated on September 22, 2011

Sponsor: OHSU Knight Cancer Institute
Collaborators:
Information provided by: OHSU Knight Cancer Institute
Identifier: NCT01138137

Purpose

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.

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No
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 - SGOT/SGPT < 2.5 x institutional upper limits of normal - Performance status must be ECOG < 2 (Karnofsky ? 50) - Life expectancy of ? 60 days from the date of registration Exclusion Criteria: - Pregnant, positive beta hCG, or lactating - History of clinically significant reactive airway disease - Active significant cardiac disease as evidenced by New York Heart Association Classification for 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.

Investigators

  • Investigator: Edward A Neuwelt, MD - Principal Investigator - Knight Cancer Institute at Oregon Health & Science University

Locations

  • Oregon Health & Science University

    Portland, Oregon 97239 United States

Conditions related to this trial:

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