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Temozolomide or Dacarbazine in Treating Patients With Stage IV Melanoma
This study is ongoing, but not recruiting participants.
Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00101218
  Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether temozolomide is more effective than dacarbazine in treating melanoma.

PURPOSE: This randomized phase III trial is studying temozolomide to see how well it works compared to dacarbazine in treating patients with stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: dacarbazine
Drug: temozolomide
Phase III

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Temozolomide Dacarbazine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: Extended Schedule, Escalated Dose Temozolomide Versus Dacarbazine In Stage IV Metastatic Melanoma: A Randomized Phase III Study Of The EORTC Melanoma Group

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Duration of survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Best response in patients with measurable disease as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Duration of response (complete response and partial response) [ Designated as safety issue: No ]
  • Toxicity as assessed by CTCAE v3 [ Designated as safety issue: Yes ]

Estimated Enrollment: 880
Study Start Date: October 2004
Detailed Description:

OBJECTIVES:

Primary

  • Compare overall survival of patients with stage IV melanoma treated with temozolomide vs dacarbazine.

Secondary

  • Compare progression-free survival of patients treated with these drugs.
  • Compare objective response rate and duration of objective response in patients with measurable disease treated with these drugs.
  • Compare the safety and tolerability of the dose-dense schedule of temozolomide in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral temozolomide once daily on days 1-7, 15-21, and 29-35. Treatment repeats every 42 days.
  • Arm II: Patients receive dacarbazine IV over 1-2 hours on day 1. Treatment repeats every 21 days.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.

Patients with stable or responding disease who discontinue study treatment due to unacceptable toxicity are followed every 9 weeks.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 880 (440 per treatment arm) patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma

    • Stage IV disease (e.g., disease in 2 nodal basins)
    • Mucosal and unknown primary disease allowed
  • Surgically incurable or unresectable disease
  • No ocular melanoma
  • Evaluable disease

    • No metatatic disease confirmed by positron-emission tomography (PET)
  • No clinical evidence of brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1 OR
  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin > 10 g/dL

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
  • Lactic dehydrogenase ≤ 2 times ULN

Renal

  • Creatinine ≤ 1.5 ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
  • No known clinically uncontrolled infectious disease
  • No known HIV positivity
  • No AIDS-related disease
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • No other malignancy within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior adjuvant cytokine or vaccine therapy for resected stage I-III disease
  • At least 4 weeks since prior vaccine therapy for stage IV disease
  • At least 4 weeks since prior cytokine therapy by isolated limb perfusion for locoregional disease
  • No prior cytokine therapy for stage IV disease
  • No concurrent immunotherapy
  • No concurrent biologic therapy

Chemotherapy

  • No prior chemotherapy for stage IV disease
  • At least 4 weeks since prior chemotherapy by isolated limb perfusion for locoregional disease
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • Recovered from prior major surgery
  • At least 4 weeks since prior palliative surgery for stage IV disease

    • No prior radical surgery for stage IV disease

Other

  • Recovered from prior adjuvant therapy
  • No other concurrent investigational drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101218

Locations
Brazil
Faculdade De Medicina Do ABC
Santo Andre, Brazil, 09060-650
France
Hopital Bichat - Claude Bernard
Paris, France, 75018
Hopital Cochin
Paris, France, 75674
Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Southwest German Cancer Center at Eberhard-Karls-University
Tuebingen, Germany, D-72076
Philipps-Universitaet Marburg Klinikum
Marburg, Germany, D-35033
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
United Kingdom, England
Broomfield Hospital
Chelmsford, Essex, England, United Kingdom, CM1 7ET
Guy's Hospital
London, England, United Kingdom, SE1 9RT
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
St. George's Hospital
London, England, United Kingdom, SW17 0QT
United Kingdom, Scotland
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom, DD1 9SY
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Poulam Patel, MBBS, PhD, FRCP Nottingham City Hospital NHS Trust
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000404360, EORTC-18032, SPRI-PO3267, EUDRACT-2004-000654-23
Study First Received: January 7, 2005
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00101218  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Dacarbazine
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Temozolomide
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009