At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed stage IV metastatic melanoma that is surgically incurable
- ✓Age 18 years or older
- ✓ECOG performance status of 0 or 1
- ✓Disease-free from any prior cancer for 5 years (except cervical carcinoma in-situ or skin basal/squamous cell carcinoma)
- ✕Ocular melanoma
- ✕Brain metastases
- ✕Prior cytokine or chemotherapy for stage IV disease
- ✕Pregnant or nursing women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
In Brief
A Phase 3 clinical trial evaluating Temozolomide and Dacarbazine for Melanoma. Completed, enrolled 859 participants.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
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.