Phase 3
Completed N=859
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Source: ClinicalTrials.gov NCT00091572 ↗Enrolled (actual)
859
Serious AEs
26.7%
Results posted
Mar 2009
Primary outcomePrimary: Overall Survival — 9.13; 9.36 Months — p=0.9999
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
9.13; 9.36 | 0.9999 |
| SECONDARY Progression Free Survival |
2.30; 2.17 | 0.2663 |
| SECONDARY Objective Response Rate in Subjects With Measurable Lesions |
0.14; 0.10 | 0.0718 |
| SECONDARY Duration of Objective Response |
4.34; 8.31 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00091572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.