Trial · NCT00091572

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

NCT00091572, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-03-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267). Trials, record NCT00091572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00091572

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)
NCT number: NCT00091572
Status: Completed
Phases: Phase 3
Enrollment: 859 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Melanoma
Interventions: Temozolomide, Dacarbazine
First posted: 2004-09-14
Last updated: 2017-06-06
Results first posted: 2009-03-12

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	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.
Secondary	Progression Free Survival	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.
Secondary	Objective Response Rate in Subjects With Measurable Lesions	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.
Secondary	Duration of Objective Response	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Progression Free Survival	Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.	Intent to Treat Population	Months	MEDIAN
PRIMARY	Overall Survival	The final analysis was to be performed when at least 616 deaths had occurred.	Intent to Treat Population	Months	MEDIAN
SECONDARY	Objective Response Rate in Subjects With Measurable Lesions	Treatment continued until disease progression or unacceptable toxicity.	Intent to treat population with measurable disease at Baseline.	Ratio	MEDIAN
SECONDARY	Duration of Objective Response	Treatment continued until disease progression or unacceptable toxicity.	All responders	Months	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival	Temozolomide	2.30	95% Confidence Interval 2.23 to 2.43	Months
Progression Free Survival	Dacarbazine	2.17	95% Confidence Interval 2.14 to 2.27	Months
Overall Survival	Temozolomide	9.13	95% Confidence Interval 8.11 to 9.89	Months
Overall Survival	Dacarbazine	9.36	95% Confidence Interval 8.21 to 10.28	Months
Objective Response Rate in Subjects With Measurable Lesions	Temozolomide	0.14	95% Confidence Interval 0.10 to 0.17	Ratio
Objective Response Rate in Subjects With Measurable Lesions	Dacarbazine	0.10	95% Confidence Interval 0.07 to 0.12	Ratio
Duration of Objective Response	Temozolomide	4.34	95% Confidence Interval 4.17 to 6.18	Months
Duration of Objective Response	Dacarbazine	8.31	95% Confidence Interval 6.08 to 19.25	Months

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Temozolomide	429
Overall Study	STARTED	Dacarbazine	430
Overall Study	COMPLETED	Temozolomide	334
Overall Study	COMPLETED	Dacarbazine	348
Overall Study	NOT COMPLETED	Temozolomide	95
Overall Study	NOT COMPLETED	Dacarbazine	82

Source ClinicalTrials.gov

Adverse events380

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ABDOMINAL PAIN	Gastrointestinal disorders	Temozolomide	43	419	91
other	ABDOMINAL PAIN	Gastrointestinal disorders	Dacarbazine	31	421	58
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Temozolomide	22	419	43
other	ABDOMINAL PAIN UPPER	Gastrointestinal disorders	Dacarbazine	17	421	33
other	CONSTIPATION	Gastrointestinal disorders	Temozolomide	183	419	563
other	CONSTIPATION	Gastrointestinal disorders	Dacarbazine	111	421	267
other	DIARRHOEA	Gastrointestinal disorders	Temozolomide	79	419	146
other	DIARRHOEA	Gastrointestinal disorders	Dacarbazine	71	421	139
other	DYSPEPSIA	Gastrointestinal disorders	Temozolomide	22	419	85
other	DYSPEPSIA	Gastrointestinal disorders	Dacarbazine	25	421	47

1 to 10 of 380Source ClinicalTrials.gov

See all 380 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Temozolomide
Total, all-cause mortality	Dacarbazine
Total, other adverse events	Temozolomide	394	419
Total, other adverse events	Dacarbazine	374	421
Total, serious adverse events	Temozolomide	124	419
Total, serious adverse events	Dacarbazine	100	421

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21600759	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Temozolomide vs Dacarbazine: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00091572

GET https://conductscience.org/api/trials/v1/NCT00091572/events?page=2

API reference For AI assistants