Brief Title
Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)
Official Title
1102C-T. Pharmacology Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients With Metastatic or Recurrent Cancer of the Endometrium. Tissue Submission for Patients With Endometrial Cancer.
Brief Summary
The purpose of this study is to determine the amount of Aerosolized Liposomal-Nitro-20
(S)-Camptothecin (L9NC) in a patients blood and tumor.
Detailed Description
Patients on this study are being asked to allow the researchers to take a piece of some
normal endometrial tissue and tumor tissue. No additional endometrial tissue will be taken
for this study other than what is surgically indicated to resect the patients tumor
completely. Prior to this surgery, patients will receive one more dose of L9NC in the
outpatient clinic in the same manner as the other L9NC treatments they have received. After
the tumor has been removed, the tissue will be examined by a pathologist, who will take what
is needed to diagnose the residual disease. What is not needed for patient care will be used
for research. A piece of the tumor and some normal endometrial tissue surrounding the tumor
will be sent to the Investigational Drug Program laboratory, which is located in the Cancer
Center, to measure the amount of drug that is left in the patients tumor. The patients tissue
will be kept until all tissues are collected from all patients, which could take up to 10
years. The tissue will not be used for any other purpose. The samples will be labeled with
the patients initials.
Study Type
Observational
Condition
Corpus Uteri
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
6
Start Date
August 2003
Completion Date
August 2007
Primary Completion Date
April 2007
Eligibility Criteria
Inclusion Criteria:
- Patients participating in Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)-
Camptothecin (L9NC) in Patients with Metastatic or Recurrent Cancer of the Endometrium
are eligible.
Exclusion Criteria:
- Not specified.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Claire F Verschraegen, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00250016
Organization ID
1102C-T
Study Sponsor
University of New Mexico
Study Sponsor
Claire F Verschraegen, MD, Principal Investigator, University of New Mexico
Verification Date
March 2008