Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

Browse trials for

• Melanoma 3,006

Keywords

• Metastatic Melanoma

Melanoma

3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.

This study's enrollment of 859 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 132 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  A

  temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)

  Drug: Temozolomide

• Active comparator
  B

  dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks

  Drug: Dacarbazine

Interventions

• DrugTemozolomide

  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.

  Also known as: Temodal, Temodar, SCH 52365

• DrugDacarbazine

  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.

  Also known as: DTIC-Dome

Primary outcomes

1. Overall Survival

   Overall Survival was defined as the time from the date of randomization to the date of death from any cause.

   Time frame: The final analysis was to be performed when at least 616 deaths had occurred.

Secondary outcomes

1. Progression Free 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.

   Time frame: Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.

2. Objective Response Rate in Subjects With Measurable Lesions

   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.

   Time frame: Treatment continued until disease progression or unacceptable toxicity.

3. Duration of Objective Response

   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.

   Time frame: Treatment continued until disease progression or unacceptable toxicity.

Baseline characteristics

Publications

• Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18. PubMed 21600759 ↗

Individual participant data

Plan to share: Yes — http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php