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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Drug: Dacarbazine; Drug: Temozolomide

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00091572

P03267

Details and patient eligibility

About

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.

Enrollment: 859 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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859 participants in 2 patient groups

A

Experimental group

Description:

temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)

Treatment:

Drug: Temozolomide

B

Active Comparator group

Description:

dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks

Treatment:

Drug: Dacarbazine