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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00101218 |
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 |
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 |
Estimated Enrollment: | 880 |
Study Start Date: | October 2004 |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed melanoma
Evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
At least 4 weeks since prior palliative surgery for stage IV disease
Other
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 |
Investigator: | Poulam Patel, MBBS, PhD, FRCP | Nottingham City Hospital NHS Trust |
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 |
recurrent melanoma stage IV melanoma |
Neuroectodermal Tumors Dacarbazine Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Temozolomide Recurrence Neuroendocrine Tumors Melanoma |
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 |