Study of Weekly LOC-paclitaxel Injection for Melanoma
|ClinicalTrials.gov Identifier: NCT01039844|
Recruitment Status : Terminated (Poor Accrual)
First Posted : December 25, 2009
Last Update Posted : October 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: LOC-paclitaxel||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Weekly LOC-paclitaxel Injection|
|Study Start Date :||December 2009|
|Primary Completion Date :||February 2016|
|Study Completion Date :||February 2016|
Experimental: Weekly LOC-paclitaxel Injection
LOC-paclitaxel IV by a 1 hour infusion on Day 1, 8, 15, 22 and 29; repeated every 42 days (6 weeks) per cycle.
Phase I Starting Dose: 100 mg/m^2 IV (intravenously) 1 hour infusion on Day 1, 8, 15, 22 and 29; and repeated every 42 days (6 weeks) per cycle.
Phase II Starting Dose: Maximum tolerated dose from Phase I.
- Maximum Tolerated Dose (MTD) of LOC-Paclitaxel [ Time Frame: 6 week cycles ]MTD defined as the dose of LOC-paclitaxel at which no more than 2 of 6 patients experience dose limiting toxicity (DLT).
- Toxicity of Weekly LOC-Paclitaxel [ Time Frame: Day 1 of each 6 week cycle ]Toxicity will be graded according to the NCI Common Toxicity Criteria (CTC), Version 3.0.
- Tumor Response [ Time Frame: 6 weeks ]
The Response Evaluation Criteria in Solid Tumors (RECIST) used to assess tumor response to treatment in this study. Complete Response (CR): disappearance of all target lesions determined by two consecutive observations not less than four weeks apart. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD determined by two consecutive observations not less than four weeks apart.
Progression (PD): at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039844
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Rodabe N. Amaria, MD||M.D. Anderson Cancer Center|