Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267AM2)(COMPLETED) - Full Text View

Sponsors and Collaborators:	Schering-Plough European Organization for Research and Treatment of Cancer
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00091572

Purpose

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.

Condition	Intervention	Phase
Melanoma	Drug: Temozolomide Drug: Dacarbazine	Phase III

MedlinePlus related topics: Melanoma

Drug Information available for: Temozolomide Dacarbazine Disulfiram

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Overall Survival [ Time Frame: The final analysis will be done when 616 deaths have occurred. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression Free Survival Objective Tumor Response rate in patients with measurable lesions duration of objective response safety and tolerability of the dose-dense schedule of TMZ [ Time Frame: Treatment continues until disease progression or unacceptable toxicity. Patients will be followed for survival. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	850
Study Start Date:	July 2004
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)	Drug: 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.
B: Active Comparator dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed, stage IV, surgically incurable melanoma
Age 18 years or older
WHO (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091572

Sponsors and Collaborators

Schering-Plough

European Organization for Research and Treatment of Cancer

Investigators

Principal Investigator:

Poulam Patel, MD

Nottingham City Hospital

More Information

Responsible Party:	Schering-Plough ( Susan Arbuck, MD - Vice President, Global Clinical Research, Oncology )
Study ID Numbers:	P03267
Study First Received:	September 10, 2004
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00091572
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Metastatic Melanoma

Study placed in the following topic categories:

Disulfiram
Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal

Neuroepithelioma
Nevus
Temozolomide
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009