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

NCT ID: NCT00091572

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 859 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-20
• Study Completion Date: 2007-12-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

B

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

Group Type: ACTIVE_COMPARATOR

Dacarbazine

Intervention Type: DRUG

intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

Interventions

Temozolomide

oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

Intervention Type: DRUG

Dacarbazine

intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

Intervention Type: DRUG

Other Intervention Names

Temodal, Temodar, SCH 52365; DTIC-Dome

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Patel PM, Suciu S, Mortier L, Kruit WH, Robert C, Schadendorf D, Trefzer U, Punt CJ, Dummer R, Davidson N, Becker J, Conry R, Thompson JA, Hwu WJ, Engelen K, Agarwala SS, Keilholz U, Eggermont AM, Spatz A; EORTC Melanoma Group. Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer. 2011 Jul;47(10):1476-83. doi: 10.1016/j.ejca.2011.04.030. Epub 2011 May 18.

Reference Type: RESULT

PMID: 21600759 (View on PubMed)

Other Identifiers

P03267

Identifier Type: -

Identifier Source: org_study_id

NCT00101218

Identifier Type: -

Identifier Source: nct_alias