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

NCT00091572 | Completed Phase 3 Results DMC

• 1 other identifier: P03267
• Study Type: interventional
• Target: 859
• Locations: 0 countries
• Sites: N/A

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

Keywords

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival was defined as the time from the date of randomization to the date of death from any cause.

  The final analysis was to be performed when at least 616 deaths had occurred.

Secondary Outcomes (3)

• Progression Free Survival

  Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.

• Objective Response Rate in Subjects With Measurable Lesions

  Treatment continued until disease progression or unacceptable toxicity.

• Duration of Objective Response

  Treatment continued until disease progression or unacceptable toxicity.

Study Arms (2)

A

EXPERIMENTAL

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

Drug: Temozolomide

B

ACTIVE COMPARATOR

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

Drug: Dacarbazine

Interventions

Temozolomide 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.

Also known as: Temodal, Temodar, SCH 52365

A

Dacarbazine 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.

Also known as: DTIC-Dome

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ocular melanomas
• Brain Metastases
• Prior cytokine or chemotherapy for stage IV disease
• Pregnant or nursing women

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Related Publications (1)

• 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.

  PMID: 21600759 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2004
• First Posted: September 14, 2004
• Study Start: October 20, 2004
• Primary Completion: December 31, 2007
• Study Completion: December 31, 2007
• Last Updated: June 6, 2017
• Results First Posted: March 12, 2009

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share