Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer
Cisplatin, Irinotecan and Bevacizumab (NSC# 704865) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To determine the percentage of patients with extensive stage small cell lung cancer treated with cisplatin, irinotecan and bevacizumab who live longer than 12 months.
SECONDARY OBJECTIVES:
I. To assess the response rate of patients treated with cisplatin, irinotecan and bevacizumab.
II. To evaluate the toxicity and tolerability of the combination of cisplatin, irinotecan and bevacizumab.
III. To determine the association between VEGF/KDR complex expression and VEGF plasma levels and tumor response.
OUTLINE:
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 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
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Illinois
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Chicago、Illinois、アメリカ、60606
- Cancer and Leukemia Group B
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Rhode Island Hospital
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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:
- All patients must have histologically or cytologically documented small cell carcinoma of the bronchus
- The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastases, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy
- Measurable or Non-measurable Disease
- No prior chemotherapy or investigational therapy for SCLC
- Radiation therapy must have been completed at least three weeks before initiation of protocol therapy
- No major surgical procedure within 28 days prior to starting treatment and fully recovered
- No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to starting treatment
- ECOG performance status: 0-2
- No "currently active" second malignancy other than non-melanoma skin cancers
- No CNS metastases; patients with a history of CNS metastases will NOT be eligible even if they have completed a course of CNS radiotherapy; all patients will have a screening brain CT or MRI to rule out occult CNS metastases
- No recent history of CVA (within 6 months)
- No serious or non-healing wound ulcer or bone fracture
- Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible
- No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher)
- Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy
- No HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with the protocol treatment; (patients with immune deficiency are at an increased risk of lethal infections when treated with marrow-suppressive therapy)
- No chronic daily treatment with aspirin (> 325 mg/day) or on non-steroidal antiinflammatory agents known to inhibit platelet function; no treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), cilostazol (Pletal), or other antiplatelet agents
- No clinically significant peripheral neuropathy (grade >= 2)
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No treatment with therapeutic anticoagulation; prophylactic anticoagulation for central venous access devices is allowed provided requirements of INR < 1.5 and PTT < 1.2 x ULN are met; caution should be taken in treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis as there may be an increased bleeding risk with bevacizumab
- No current and/or recent (within 1 month) use of a thrombolytic agent; low dose thrombolytic therapy for maintenance of central venous catheter is allowed
- No clinically significant peripheral arterial disease
- Non-pregnant and non-nursing; the effect of the combination of bevacizumab, cisplatin, and irinotecan on the fetus and infant is unknown
- Granulocytes >= 1,500/μl
- Platelets >= 100,000/μl
- Serum Creatinine =< ULN
- Total Bilirubin < 2.0 mg/dl
- SGOT < 2 x ULN
- INR < 1.5
- PTT < 1.2 x ULN
- Urine protein (dipstick) < 1+
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:なし
- 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 |
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実験的:Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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相関研究
与えられた IV
他の名前:
与えられた IV
他の名前:
与えられた IV
他の名前:
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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 |
---|---|---|
Survival time
時間枠:The time beginning at randomization until death or last known follow-up, assessed up to 4 years
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Described using Kaplan-Meier curves.
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The time beginning at randomization until death or last known follow-up, assessed up to 4 years
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Failure-free survival
時間枠:The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years
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Described using Kaplan-Meier curves.
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The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Frequency of toxicity, tabulated by the most severe occurrence
時間枠:Up to 4 years
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Graded using the NCI CTCAE version 3.0.
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Up to 4 years
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協力者と研究者
捜査官
- 主任研究者:Neal Ready、Cancer and Leukemia Group B
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 (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
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2012-02815 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
- U10CA031946 (米国 NIH グラント/契約)
- P30CA014236 (米国 NIH グラント/契約)
- CDR0000433341
- CALGB-30306 (その他の識別子:CTEP)
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。
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