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MelanomaPhase 3NCT00091572

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

A Phase 3 study testing Temozolomide and Dacarbazine in people with Melanoma, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Temozolomide and Dacarbazine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
859 participants
Where
No sites listed yet
Study dates
20 Oct 2004to 31 Dec 2007
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 10Show fewer
  • 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

Who cannot join

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

About this 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

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
Being tested
Temozolomide, Dacarbazine
Keywords
Metastatic Melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemozolomideDrug

    Also called Temodal, Temodar, SCH 52365

    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.

  • DacarbazineDrug

    Also called DTIC-Dome

    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.

Study groups in NCT00091572
Study groupRoleWhat they receive
AExperimentaltemozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
Receives: Drug: Temozolomide
BActive comparatordacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
Receives: Drug: Dacarbazine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

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

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

Secondary outcomes (3)

  1. 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.

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

  2. 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.

    Measured: Treatment continued until disease progression or unacceptable toxicity.

  3. 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.

    Measured: Treatment continued until disease progression or unacceptable toxicity.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2004 (estimated)
  2. Study start20 Oct 2004
  3. Primary completion31 Dec 2007
  4. Study completion31 Dec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
859 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091572
Sponsor's protocol ID
P03267
Status last verified
May 2017
First submitted
10 Sep 2004
Last updated
6 Jun 2017
Data monitoring committee
Yes
Individual data sharing
Yes: 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

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.

    PubMed 21600759

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Temozolomide and Dacarbazine in people with Melanoma, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: The final analysis was to be performed when at least 616 deaths had occurred.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091572, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.

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