Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)

Phase 3

Completed

• Conditions: Melanoma
• Interventions: Drug: Temozolomide; Drug: Dacarbazine

• Registration Number: NCT00091572
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-09-10
• Study First Submitted QC: 2004-09-13
• Study First Posted: 2004-09-14
• Study Start: 2004-10-20
• Primary Completion: 2007-12-31
• Study Completion: 2007-12-31
• Results First Submitted: 2008-12-19
• Results First Submitted QC: 2009-02-05
• Results First Posted: 2009-03-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-12
• Last Update Posted: 2017-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 859

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Temozolomide	temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
B	Dacarbazine	dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks

Primary Outcome Measures

Name	Time	Method
Overall Survival	The final analysis was to be performed when at least 616 deaths had occurred.	Overall Survival was defined as the time from the date of randomization to the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.	Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.
Objective Response Rate in Subjects With Measurable Lesions	Treatment continued until disease progression or unacceptable toxicity.	Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
Duration of Objective Response	Treatment continued until disease progression or unacceptable toxicity.	Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.