CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00270907|
Recruitment Status : Completed
First Posted : December 29, 2005
Last Update Posted : February 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Breast Cancer||Drug: CT-2103 Drug: Gemcitabine||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: CT-2103 + Gemcitabine
CT-2103 135 mg/m^2 intravenous (IV) on Day 1. Gemcitabine 1000 mg/m^2 IV on Day 1 and 8.
135 mg/m^2 IV on Day 1.
Other Name: Xyotax
1000 mg/m^2 IV on Day 1 and 8.
Other Name: Gemzar
- Maximum Tolerated Dose (MTD) of CT-2103 [ Time Frame: 21 days ]MTD defined as the level of CT-2103 at which 2 out of 6 patients had dose limiting toxicity (DLT) where the primary DLT events of CT-2103 are uncomplicated neutropenia, febrile neutropenia, and/or grade 3 neuropathy. Assessments during the first cycle of therapy, where cycle is 21 days.
- Number of Participants with Response [ Time Frame: 6 weeks following chemotherapy ]Evaluation of response in participants with measurable disease after each 6 weeks of chemotherapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270907
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marjorie Green, MD||M.D. Anderson Cancer Center|