CT-2103 in Combination With Gemcitabine in Metastatic Breast Cancer
|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
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|