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

May 12, 2017 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

859

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • DTIC-Dome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The final analysis was to be performed when at least 616 deaths had occurred.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.
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.
Treatment continued until disease progression or unacceptable toxicity.
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.
Treatment continued until disease progression or unacceptable toxicity.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2004

Primary Completion (Actual)

December 31, 2007

Study Completion (Actual)

December 31, 2007

Study Registration Dates

First Submitted

September 10, 2004

First Submitted That Met QC Criteria

September 13, 2004

First Posted (Estimate)

September 14, 2004

Study Record Updates

Last Update Posted (Actual)

June 6, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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