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

This study has been completed.
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00091572
First received: September 10, 2004
Last updated: May 21, 2014
Last verified: May 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: The final analysis was to be performed when at least 616 deaths had occurred. ] [ Designated as safety issue: No ]
    Overall Survival was defined as the time from the date of randomization to the date of death from any cause.


Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment continued until disease progression or unacceptable toxicity. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Treatment continued until disease progression or unacceptable toxicity. ] [ Designated as safety issue: No ]
    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.


Enrollment: 859
Study Start Date: October 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
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.
Other Name: Temodal, Temodar, SCH 52365
Active Comparator: B
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.
Other Name: DTIC-Dome

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00091572     History of Changes
Obsolete Identifiers: NCT00101218
Other Study ID Numbers: P03267
Study First Received: September 10, 2004
Results First Received: December 19, 2008
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Metastatic Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014