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Trial record 84 of 520 for:    melanoma phase III

Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072124
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as dacarbazine and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Complete metastasectomy may be an effective treatment for metastatic melanoma and may improve quality of life and help patients live longer and more comfortably. It is not yet known whether complete metastasectomy is more effective than chemotherapy in treating stage IV melanoma.

PURPOSE: This randomized phase III trial is studying dacarbazine and/or cisplatin to see how well they work compared to complete metastasectomy in treating patients with stage IV melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: cisplatin Drug: dacarbazine Procedure: conventional surgery Phase 3

Detailed Description:



  • Compare overall survival in patients with stage IV melanoma treated with complete metastasectomy vs dacarbazine and/or cisplatin.


  • Compare time to progression in patients treated with these regimens.
  • Determine the response rate in patients treated with dacarbazine and/or cisplatin.
  • Compare the morbidity and quality of life of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to prior exposure to dacarbazine and cisplatin (yes vs no) and number of sites of metastases (1 vs 2 or more). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (surgery): Patients undergo complete metastasectomy. Patients with disease progression after surgery may undergo repeat resection or may receive dacarbazine and/or cisplatin as in arm II.
  • Arm II (systemic therapy): Patients receive dacarbazine IV over 30-60 minutes and/or cisplatin IV over 30 minutes on days 1, 2, 3, 22, 23, and 24 (1 course). Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 1 additional course of chemotherapy beyond CR and are eligible for other investigational strategies.

Quality of life is assessed at baseline, at 3 and 6 months, and at 1 year.

Patients are followed every 3-4 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this study within 4 years.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
Study Start Date : September 2003
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of metastatic melanoma

    • Solitary pulmonary nodule may not be sole site of metastatic disease
    • No disease limited to subcutaneous, cutaneous, or peripheral nodal (neck, axillary, groin, or iliac nodes) sites only
  • Measurable disease
  • Disease progression during or after prior interleukin-2 (IL-2)-based therapy OR ineligible for high-dose IL-2 therapy
  • Metastatic disease amenable to complete surgical resection

    • Less than 5% estimated mortality from surgery
    • Prior complete metastasectomy allowed provided disease did not recur within 6 months after surgery
  • No primary ocular or mucosal melanoma
  • No brain metastases



  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • WBC at least 3,000/mm^3 OR
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No coagulation disorder


  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Creatinine no greater than 1.6 mg/dL OR
  • Creatinine clearance at least 70 mL/min
  • No major medical illness of the renal system


  • No major medical illness of the cardiovascular system


  • No major medical illness of the respiratory system


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No active systemic infection
  • No form of primary or secondary immunodeficiency


Biologic therapy

  • See Disease Characteristics


  • Not specified

Endocrine therapy

  • Not specified


  • No concurrent palliative radiotherapy


  • See Disease Characteristics
  • No concurrent palliative surgery


  • More than 3 weeks since prior therapy for melanoma (except surgery)
  • No other concurrent therapy for melanoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072124

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Richard M. Sherry, MD NCI - Surgery Branch

Layout table for additonal information Identifier: NCT00072124     History of Changes
Obsolete Identifiers: NCT00068939
Other Study ID Numbers: CDR0000335471
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: January 2005
Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents