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| Sponsored by: |
University of New Mexico |
|---|---|
| Information provided by: | University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT00250016 |
Purpose
The purpose of this study is to determine the amount of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in a patients blood and tumor.
| Condition |
|---|
|
Corpus Uteri Endometrial Cancer |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| 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. |
Blood sample, tumor endometrial tissue, and normal endometrial tissue.
| Enrollment: | 6 |
| Study Start Date: | August 2003 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients participating in the trial - "Phase II Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients with Metastatic or Recurrent Cancer of the Endometrium"
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| Principal Investigator: | Claire F Verschraegen, MD | University of New Mexico |
More Information
| Responsible Party: | University Of New Mexico - CRTC ( Claire F. Verschraegen, M.D.; Principal Investigator ) |
| Study ID Numbers: | 1102C-T |
| Study First Received: | November 3, 2005 |
| Last Updated: | March 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00250016 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Endometrium Tissue L9NC |
|
Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Endometrial Cancer |
Urogenital Neoplasms 9-nitrocamptothecin Antineoplastic Agents, Phytogenic Camptothecin Recurrence |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Genital Neoplasms, Female Uterine Diseases Enzyme Inhibitors Urogenital Neoplasms 9-nitrocamptothecin Pharmacologic Actions |
Camptothecin Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Uterine Neoplasms Antineoplastic Agents, Phytogenic |
