Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal 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: NCT00971841|
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : July 19, 2013
Last Update Posted : July 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer|
|Study Start Date :||March 2008|
|Primary Completion Date :||April 2012|
|Study Completion Date :||April 2012|
One hour intravenous infusion on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consists of 49 days. Day 1 dose same level as last dose of original Study CA139-540 (100mg/m2, 80 mg/m2, or 60 mg/m2). Treatment to continue until disease progression or unacceptable toxicity apparent.
- Number of Adverse Events (AEs) Per Participant [ Time Frame: Weekly Day 1 to 4 years ]AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Severity of the adverse event was judged and graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0.
- Number of Participants With Complete Response to Tumor [ Time Frame: Every 7 weeks Day 1 to 4 years ]Tumor measured/evaluated via imaging and assessed according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.0 wherein complete response is disappearance of all target lesions; partial response is 30% decrease in the sum of the longest diameter of target lesions; progressive disease is 20% increase in the sum of the longest diameter of target lesions, and stable disease is small changes that do not meet above criteria. The baseline assessment was done prior to the first administration of drug in the original Study CA139-540 (NCT 00344552).
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): NCT00971841
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|