Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
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|ClinicalTrials.gov Identifier: NCT00091572|
Recruitment Status : Completed
First Posted : September 14, 2004
Results First Posted : March 12, 2009
Last Update Posted : June 6, 2017
Merck Sharp & Dohme Corp.
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Temozolomide Drug: Dacarbazine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||859 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group|
|Actual Study Start Date :||October 20, 2004|
|Actual Primary Completion Date :||December 31, 2007|
|Actual Study Completion Date :||December 31, 2007|
Resource links provided by the National Library of Medicine
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
Other Name: Temodal, Temodar, SCH 52365
Active Comparator: B
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.
Other Name: DTIC-Dome
Primary Outcome Measures :
- Overall Survival [ Time Frame: The final analysis was to be performed when at least 616 deaths had occurred. ]Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Secondary Outcome Measures :
- Progression Free Survival [ Time Frame: Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival. ]Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.
- Objective Response Rate in Subjects With Measurable Lesions [ Time Frame: Treatment continued until disease progression or unacceptable toxicity. ]Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
- Duration of Objective Response [ Time Frame: Treatment continued until disease progression or unacceptable toxicity. ]Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.
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