Primary Peritoneal Carcinoma Clinical Trial
Official title:
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
Verified date | April 2017 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the MTD and assess the toxicity of IV NAC | The MTD of IV NAC will be defined as one dose level below that which produces NCI Common Toxicity Criteria (CTC) grade 3 or 4 non-hematologic toxicity in 20% of subjects. The toxicity of NAC can be differentiated from that of the chemotherapeutic drugs as the half-life of NAC is very short and adverse effects are seen either during or very soon after the administration of NAC. | 4 years | |
Secondary | To describe tumor response | 4 years | ||
Secondary | To describe the incidence and severity of nephrotoxicity | 4 years | ||
Secondary | To describe the incidence and severity of hearing loss | 4 years | ||
Secondary | To describe the incidence and severity of peripheral and autonomic neuropathy | 4 years |
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