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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cisplatin
dacarbazine
conventional surgery
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic 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 Hepatic Hepatitis B surface antigen negative Hepatitis C antibody negative Renal Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 70 mL/min No major medical illness of the renal system Cardiovascular No major medical illness of the cardiovascular system Pulmonary No major medical illness of the respiratory system Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No concurrent palliative radiotherapy Surgery See Disease Characteristics No concurrent palliative surgery Other More than 3 weeks since prior therapy for melanoma (except surgery) No other concurrent therapy for melanoma

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 4, 2003
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00072124
Brief Title
Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
Official Title
A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Compare overall survival in patients with stage IV melanoma treated with complete metastasectomy vs dacarbazine and/or cisplatin. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
dacarbazine
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 16 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic 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 Hepatic Hepatitis B surface antigen negative Hepatitis C antibody negative Renal Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 70 mL/min No major medical illness of the renal system Cardiovascular No major medical illness of the cardiovascular system Pulmonary No major medical illness of the respiratory system Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy No concurrent palliative radiotherapy Surgery See Disease Characteristics No concurrent palliative surgery Other More than 3 weeks since prior therapy for melanoma (except surgery) No other concurrent therapy for melanoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M. Sherry, MD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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