Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer
Phase II Trial of Neoadjuvant Therapy With Carboplatin and Gemcitabine With Thalidomide in Patients With Stage II and IIIA Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and gemcitabine together with thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving carboplatin and gemcitabine together with thalidomide works in treating patients who are undergoing surgery for stage II or stage III non-small cell lung cancer.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with stage II or IIIA non-small cell lung cancer treated with neoadjuvant carboplatin, gemcitabine hydrochloride, and thalidomide.
Secondary
- Determine, preliminarily, the mechanism of action and activity of thalidomide against lung cancer.
- Determine the 1-year and 2-year survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the operative mortality of patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive carboplatin intravenously (IV) over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks after the completion of chemotherapy, patients with resectable tumors undergo surgical resection.
After completion of study treatment, patients are followed every 3 months for 2 years.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota Cancer Center
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Robbinsdale、Minnesota、アメリカ、55422-2900
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
-
-
New Hampshire
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Lebanon、New Hampshire、アメリカ、03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
-
-
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
Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell undifferentiated carcinoma
- Stage II or IIIA disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
- No tumor involving the superior sulcus (e.g., Pancoast tumor)
- Karnofsky performance status 70-100%
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 2 mg/dL
- Bilirubin < 2 mg/dL
- Aspartate aminotransferase (AST) < 3 times upper limit of normal
Exclusion Criteria:
Pregnant or nursing
- No nursing during and for ≥ 4 weeks after completion of study treatment
- Positive pregnancy test
- Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
- Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
- Blood, sperm, or ova donation during study treatment
- Post obstructive pneumonia
- Other serious infection or medical illness that would preclude study participation
- Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years
- Less than 5 years since prior resection of lung disease
- Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
- Other concurrent chemotherapy or radiotherapy
- Concurrent hormonal therapy or immunotherapy
- Other concurrent anticancer therapy
- Other concurrent investigational agents
- Concurrent participation in another clinical study
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：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Treatment Arm
Chemotherapy treatment (carboplatin, gemcitabine and thalidomide) every 21 days for 3 courses.
|
Day 1 of Cycles 1, 2 and 3 - intravenously (IV) 30 minutes (Area Under the Curve = 5.5)
他の名前：
Days 1 and 8 of Cycles 1, 2 and 3 - 30 minute IV, 1000 mg/m2.
他の名前：
Oral administration: Cycle 1 - Day 1 50 mg, Day 2 100 mg, Day 3 150 mg, Day 4 and continuing until end of study treatment 200 mg.
他の名前：
Resection - between 2 and 6 weeks following last dose of chemotherapy.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients Reporting Clinical Response
時間枠：At end of 3 -21 day cycles of treatment
|
Objective clinical response measuring using tumor assessments: Complete Response (CR) = disappearance of all target and non-target lesions and normalization of tumor marker level, if applicable.
Pathological Complete Response (PCR) = No viable tumor cells in specimen determined by light microscopy.
Partial Response (PR) = at least 30% decrease in the sum of longest diameter of target lesions from baseline.
Progressive Disease (PD) = at least 20% increase in the sum of longest diameters of target lesions from baseline or new lesions.
Stable Disease (SD) = Neither PR or PD.
|
At end of 3 -21 day cycles of treatment
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients Disease-free at 1 Year
時間枠：1 year
|
Calculated from date of enrollment to date of recurrence or death, whichever came first
|
1 year
|
|
Number of Patients Disease-free at 2 Years
時間枠：2 Years
|
Calculated from date of enrollment to date of recurrence or death, whichever came first
|
2 Years
|
|
Number of Patients Alive at 1 Year (Survival)
時間枠：12 Months
|
Participants who were alive at one year from date of enrollment .
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12 Months
|
|
Number of Patients Alive at 2 Years (Survival)
時間枠：24 Months
|
Participants who were alive at 2 years from date of enrollment.
|
24 Months
|
|
Number of Patients Alive at 56 Months (End of Study)
時間枠：Up to 56 months
|
Patients alive from date of enrollment to date of death or censored at date of last contact (Overall Survival).
|
Up to 56 months
|
協力者と研究者
捜査官
- スタディチェア：Arkadiusz Dudek, MD、Masonic Cancer Center, University of Minnesota
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2002LS013
- LILLY-X-382 (その他の識別子：Eli Lilly)
- 0202M17981 (その他の識別子：IRB, University of Minnesota)
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