Stage IV Metastatic Melanoma: MedDRA version: 7.0 Level: PT Classification code 10027480
Conditions
Interventions
Trade Name: Temodal
Product Name: Temozolomide
Product Code: SCH#052365
Pharmaceutical Form: Capsule*
INN or Proposed INN: Temozolomide
CAS Number: 85622-93-1
Current Sponsor code: SCH#052365
Concent
Sponsors
EORTC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (a) Patients with histologically confirmed, surgically incurable or unresectable metastatic melanoma. (b) Patients with evidence of brain metastases are not eligible. (c) Patients must not have received any prior cytokine or chemotherapy for stage IV disease. The following are allowed: ? Adjuvant cytokine or vaccine therapy for resected stage I to III disease ? Previous vaccine therapy (other than cytokine) for stage IV disease ? Palliative surgery for stage IV disease ? Prior Cytokine or chemotherapy for local-regional disease by isolated limb perfusion therapy All patients must have discontinued prior allowable therapy for at least 4 weeks prior to randomization. (d) Patients must have WHO (ECOG) performance status of 0 or 1. (e) Age greater than or equal to 18 years. (f) Patients must have adequate hematological, renal and liver function. (g) Patients must have recovered from any effects of major surgery or previous adjuvant treatment. (h) Patients should not suffer from frequent vomiting or medical condition which could interfere with oral medication intake (eg, partial bowel obstruction). (i) Patients should not have suffered from previous cancer (unless a DFS interval of at least 5 years) or suffer from concurrent malignancies at other sites with the exception of surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin. (j) Patients should not suffer from any known clinically uncontrolled infectious disease including HIV positivity or AIDS-related illness. (k) Patients should not be pregnant or nursing. (l) Women of childbearing potential should be using an effective method of contraception. Women of childbearing potential must have a negative urine or serum pregnancy test 14 days prior to randomization and be practicing medically approved contraceptive precautions for at least 6 months after completion of treatment as directed by their physician. (m) Men should use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. (n) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial. (o) Before patient randomization, written informed consent must be obtained according to ICH/GCP, and national/local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are 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.;Secondary Objective: /;Primary end point(s): The primary end-point is the Overall Survival (OS). | — |
Countries
Belgium, Spain, United Kingdom
Outcome results
None listed