Taxotere/Temodar/Cisplatin Study in Melanoma Patients
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|ClinicalTrials.gov Identifier: NCT00527761|
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : July 30, 2012
1. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.
- To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma
- To determine the response rate of induction chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Cisplatin Drug: Docetaxel Drug: Temodar||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of TTC (Taxotere/Temodar/Cisplatin) in Metastatic Melanoma Patients|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
|Experimental: Temozolomide, Docetaxel + Cisplatin||
20 mg in 500 ml of normal saline by vein over 60 minutes daily for 4 days starting on day 1 of chemotherapy.
Other Names:Drug: Docetaxel
Starting dose 20 mg by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15).
Other Name: TaxotereDrug: Temodar
150 mg by mouth (PO) on Days 1 - 5.
Other Name: Temozolomide
- Maximum Tolerated Dose (MTD) [ Time Frame: 4 week cycles ]
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): NCT00527761
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Kevin B. Kim, MD||M.D. Anderson Cancer Center|