Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
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.
調査の概要
詳細な説明
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.
研究の種類
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
協力者と研究者
捜査官
- スタディチェア：Richard M. Sherry, MD、NCI - Surgery Branch
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000335471
- NCI-03-C-0279
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。