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

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Temozolomide
Dacarbazine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Metastatic Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    A

    B

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Overall Survival
    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
    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
    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
    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.

    Full Information

    First Posted
    September 10, 2004
    Last Updated
    May 12, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    European Organisation for Research and Treatment of Cancer - EORTC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00091572
    Brief Title
    Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
    Official Title
    Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 20, 2004 (Actual)
    Primary Completion Date
    December 31, 2007 (Actual)
    Study Completion Date
    December 31, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    European Organisation for Research and Treatment of Cancer - EORTC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melanoma
    Keywords
    Metastatic Melanoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    859 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Temozolomide
    Other Intervention Name(s)
    Temodal, Temodar, SCH 52365
    Intervention Description
    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
    Intervention Name(s)
    Dacarbazine
    Other Intervention Name(s)
    DTIC-Dome
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Overall Survival
    Description
    Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
    Time Frame
    The final analysis was to be performed when at least 616 deaths had occurred.
    Secondary Outcome Measure Information:
    Title
    Progression Free Survival
    Description
    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.
    Time Frame
    Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
    Title
    Objective Response Rate in Subjects With Measurable Lesions
    Description
    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.
    Time Frame
    Treatment continued until disease progression or unacceptable toxicity.
    Title
    Duration of Objective Response
    Description
    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.
    Time Frame
    Treatment continued until disease progression or unacceptable toxicity.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    21600759
    Citation
    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.
    Results Reference
    result

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

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