Ignite Creation Date:
2024-05-05 @ 10:34 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01138137
Status:
WITHDRAWN
Last Update Posted:
2017-04-21
First Post:
2010-06-03
Brief Title:
N-acetylcysteine Given IV With Cisplatin and Paclitaxel in Patients With Ovarian Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase I Dose Escalation Study of N-acetylcysteine NAC Administered Intravenously IV in Conjunction With Intraperitoneal IP Administered Cisplatin and IVIP Paclitaxel in Patients With Stage III or IV Ovarian Cancer
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No funding was available for the cost of the IV N-acetylcysteine NAC
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 IVIP paclitaxel in conjunction with IV NAC will limit the neurotoxicity nephrotoxicity and ototoxicity that is associated with cisplatin administration
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 IVIP paclitaxel in conjunction with IV NAC will limit the neurotoxicity nephrotoxicity and ototoxicity that is associated with cisplatin administration
Detailed Description:
OBJECTIVES
PRIMARY
To determine the Maximum Tolerated Dose MTD and assess the toxicity of IV NAC in conjunction with IP cisplatin and IVIP paclitaxel in subjects with stage 3 or 4 epithelial ovarian cancer that has been surgically debulked
SECONDARY
To describe tumor response in subjects receiving treatment for previously debulked stage 3 or 4 epithelial ovarian cancer with IP cisplatin IVIP paclitaxel and IV NAC
To describe the incidence and severity of nephrotoxicity Creatinine Clearance CrCl in subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP cisplatin IV paclitaxel and IV NAC and who have had their disease surgically debulked
To describe the incidence and severity of hearing loss in subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP cisplatin IVIP paclitaxel and IV NAC and who have had their disease surgically debulked
To describe the incidence and severity of peripheral and autonomic neuropathy in subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP cisplatin IVIP Taxol and IV NAC and who have had their disease surgically debulked
OUTLINE
Subjects will undergo chemotherapy for epithelial ovarian cancer with paclitaxel IV 135 mgm2 Day 1 and IP cisplatin 100 mgm2 Day2 followed by Taxol IP 60 mgm2 Day 8 every 3 weeks for 6 courses Sixty minutes prior to each course of IP cisplatin IV NAC starting at 150 mgkg will be infused over 30 minutes A dose escalation schema for NAC will be followed Toxicity to the therapy will be graded according to the Common Terminology Criteria for Adverse Events
PRIMARY
To determine the Maximum Tolerated Dose MTD and assess the toxicity of IV NAC in conjunction with IP cisplatin and IVIP paclitaxel in subjects with stage 3 or 4 epithelial ovarian cancer that has been surgically debulked
SECONDARY
To describe tumor response in subjects receiving treatment for previously debulked stage 3 or 4 epithelial ovarian cancer with IP cisplatin IVIP paclitaxel and IV NAC
To describe the incidence and severity of nephrotoxicity Creatinine Clearance CrCl in subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP cisplatin IV paclitaxel and IV NAC and who have had their disease surgically debulked
To describe the incidence and severity of hearing loss in subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP cisplatin IVIP paclitaxel and IV NAC and who have had their disease surgically debulked
To describe the incidence and severity of peripheral and autonomic neuropathy in subjects undergoing treatment for stage 3 or 4 epithelial ovarian cancer with IP cisplatin IVIP Taxol and IV NAC and who have had their disease surgically debulked
OUTLINE
Subjects will undergo chemotherapy for epithelial ovarian cancer with paclitaxel IV 135 mgm2 Day 1 and IP cisplatin 100 mgm2 Day2 followed by Taxol IP 60 mgm2 Day 8 every 3 weeks for 6 courses Sixty minutes prior to each course of IP cisplatin IV NAC starting at 150 mgkg will be infused over 30 minutes A dose escalation schema for NAC will be followed Toxicity to the therapy will be graded according to the Common Terminology Criteria for Adverse Events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OHSU-4229 | OTHER | OHSU IRB | None |
| 4229 | OTHER | None | None |
| SOL-08005-L | OTHER | None | None |