Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249990
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2005-11-03
Brief Title:
Phase II Study of Aerosolized Liposomal 9-Nitro-20 S- Camptothecin L9NC
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Phase II Study of Aerosolized Liposomal 9-Nitro-20 S- Camptothecin L9NC in Patients With Metastatic or Recurrent Cancer of the Endometrium
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are
11 To determine the efficacy of liposomal 9-Nitro-20 S-Camptothecin L9NC administered by aerosolization to patients with metastatic endometrial cancer
12 To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks every 10 weeks
13 To perform a pharmacology study of L9NC in the plasma and the lungs after aerosolization A specific protocol will be written for this part
11 To determine the efficacy of liposomal 9-Nitro-20 S-Camptothecin L9NC administered by aerosolization to patients with metastatic endometrial cancer
12 To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks every 10 weeks
13 To perform a pharmacology study of L9NC in the plasma and the lungs after aerosolization A specific protocol will be written for this part
Detailed Description:
RATIONALE Camptothecin CPT is a plant alkaloid isolated from Camptotheca acuminata in 1966 As a topoisomerase I inhibitor it has powerful anticancer properties and has been used clinically in the treatment of a variety of cancers It possesses significant toxicity especially involving the bone marrow and gastrointestinal tract that has limited its use Derivatives of 20-S-camptothecin have been made to increase the aqueous solubility of these compounds andor modify the A-ring to increase membrane association The 9-nitrocamptothecin 9-NC derivative to be used in this study is insoluble in water but has demonstrated potent antitumor effects in mice and antitumor effect in humans However the therapeutic index is low In order to increase the therapeutic index a liposomal formulation has been developed which can be administered as an aerosol In humans dose of 052 mgm2day 5 days per weeks for eight 8 weeks of a 10 week course were well tolerated in the Phase I study Partial responses were noted in patients with endometrial cancers The recommended starting dose of L9NC in the Phase II study is 052 mgm2day to be administered once a day by aerosol mouth-only breathing for five consecutive days per week x 8 weeks followed by a 2 week rest Courses are 10 weeks This dose corresponds to approximately 16 of the MTD of oral 9-NC administered to untreated cancer patients
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