Extended schedule, escalated dose Temozolomide versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 850

Inclusion Criteria

(a) Patients with histologically confirmed, surgically incurable or unresectable metastatic melanoma including mucosal and unknown primary.Ocular melanomas are excluded.
(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. Patients who are HIV positive or have AIDS are excluded.
(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

/

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: /;Primary end point(s): The primary end-point is the Overall Survival (OS).;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 Outcome Measures

Name	Time	Method

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