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

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ClinicalTrials.gov Identifier: NCT00091572
Recruitment Status : Completed
First Posted : September 14, 2004
Results First Posted : March 12, 2009
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 10, 2004
First Posted Date  ICMJE September 14, 2004
Results First Submitted Date  ICMJE December 19, 2008
Results First Posted Date  ICMJE March 12, 2009
Last Update Posted Date June 6, 2017
Actual Study Start Date  ICMJE October 20, 2004
Actual Primary Completion Date December 31, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
Overall Survival [ Time Frame: The final analysis was to be performed when at least 616 deaths had occurred. ]
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00091572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
  • Progression Free Survival [ Time Frame: Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival. ]
    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. ]
    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. ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
Official Title  ICMJE Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Melanoma
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: A
    temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
    Intervention: Drug: Temozolomide
  • Active Comparator: B
    dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
    Intervention: Drug: Dacarbazine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2009)
859
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
550
Actual Study Completion Date  ICMJE December 31, 2007
Actual Primary Completion Date December 31, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Belgium,   Brazil,   Chile,   Colombia,   Ecuador,   France,   Germany,   Mexico,   Netherlands,   Peru,   Portugal,   Slovenia,   South Africa,   Spain,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00091572
Other Study ID Numbers  ICMJE P03267
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP