Clinical trial · Interventional
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
NCT00091572CI-TRIAL-00028001completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dacarbazine | Drug | Dacarbazine | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
- interventionNames
- Drug: Temozolomide
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
- interventionNames
- Drug: Dacarbazine
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- The final analysis was to be performed when at least 616 deaths had occurred.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, stage IV, surgically incurable melanoma * Age 18 years or older * World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Meets protocol requirements for specified laboratory values * Must be able to take oral medication * Must be disease free from cancer for period of 5 years (except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin). * Women of childbearing potential and men must be practicing a medically approved contraception. * Must provide written informed-consent to participate in the study. * Must have full recovery from major surgery or adjuvant treatment * No clinically uncontrolled infectious disease including HIV or AIDS-related illness Exclusion Criteria: * Ocular melanomas * Brain Metastases * Prior cytokine or chemotherapy for stage IV disease * Pregnant or nursing women
References
Publications (1)
- RESULTPatel 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. PMID 21600759