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

Melanoma Clinical Trial

Official title:

Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma: A Randomized Phase III Study of the EORTC Melanoma Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00091572
• Other study ID #: P03267
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2004
• Last updated: April 28, 2015
• Start date: October 2004
• Est. completion date: December 2007

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Other known NCT identifiers

• NCT00101218

Recruitment information / eligibility

• Status: Completed
• Enrollment: 859
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.	European Organisation for Research and Treatment of Cancer - EORTC

References & Publications (1)

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, escalate — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	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.	No
Secondary	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.	Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.	No
Secondary	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.	Treatment continued until disease progression or unacceptable toxicity.	No
Secondary	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.	Treatment continued until disease progression or unacceptable toxicity.	No