Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
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|ClinicalTrials.gov Identifier: NCT00354523|
Recruitment Status : Terminated (Study closed following Phase I portion, insufficient activity to continue to Phase II.)
First Posted : July 20, 2006
Last Update Posted : December 17, 2014
To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors.
To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma.
To determine the tolerability (toxicity) of this regimen.
To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Thyroid Cancer||Drug: Capecitabine (Xeloda) Drug: DTIC-Dome (Dacarbazine) Drug: Gleevec (Imatinib Mesylate)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study to Evaluate the Efficacy and Toxicity of Imatinib Mesylate in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||August 2013|
Experimental: Capecitabine + Dacarbazine + Imatinib
Capecitabine starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle. Dacarbazine starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle. Imatinib starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
Drug: Capecitabine (Xeloda)
Starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle.
Drug: DTIC-Dome (Dacarbazine)
Starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle.
Drug: Gleevec (Imatinib Mesylate)
Starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
Other Name: Imatinib
- Maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine [ Time Frame: 21 day cycle ]The MTD is defined as the dose level below that producing dose limiting toxicity (DLT; i.e. any Grade 4 hematologic toxicity and /or non hematological toxicity >/= Grade 3 in 2/6 participants).
- Objective Response Rate [ Time Frame: Minimally 9 weeks (overall study period 5 years) ]Objective response rate is defined to be the proportion of participants achieving Complete Response (CR) or Partial Response (PR). Response to treatment will be measured using the RECIST criteria with radiological evaluation every 9 weeks.
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): NCT00354523
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James Yao, MD||M.D. Anderson Cancer Center|