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Preoperative Pemetrexed and Carboplatin for Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

2017年1月5日 更新者：SCRI Development Innovations, LLC

Phase II Trial of Preoperative Pemetrexed and Carboplatin in Patients With Select Stage IB, II, and III Non-Squamous Non-Small-Cell Lung Cancer

The purpose of this multi-center Phase II trial is to examine the impact of pemetrexed/carboplatin in the preoperative treatment of patients with select stage IB, II,and III non-squamous NSCLC. Because patients with non-squamous type NSCLC have been shown to have better survival rates than patients with squamous tumors when given pemetrexed with a platinum agent, only patients with non-squamous NSCLC (adenocarcinoma, large cell, and undifferentiated), not including squamous histology, will be allowed to participate in this study. If this novel regimen proves to be safe and active in this setting, it will provide rationale for further investigation in a larger, prospective, randomized trial.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

46

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Florida
      • Fort Myers、Florida、アメリカ、33901
        • Florida Cancer Specialists
    • Georgia
      • Augusta、Georgia、アメリカ、30901
        • Medical Oncology Associates of Augusta
      • Gainesville、Georgia、アメリカ、30501
        • Northeast Georgia Medical Center
    • Kentucky
      • Louisville、Kentucky、アメリカ、40207
        • Baptist Hospital East
    • Maryland
      • Bethesda、Maryland、アメリカ、20817
        • Center for Cancer and Blood Disorders
      • Bethesda、Maryland、アメリカ、20817
        • National Capital Clinical Research Consortium
    • Nebraska
      • Omaha、Nebraska、アメリカ、68114
        • Nebraska Methodist Cancer Center
    • Ohio
      • Cincinnati、Ohio、アメリカ、45242
        • Oncology Hematology Care
    • South Carolina
      • Columbia、South Carolina、アメリカ、29210
        • South Carolina Oncology Associates, PA
    • Tennessee
      • Chattanooga、Tennessee、アメリカ、37404
        • Chattanooga Oncology Hematology Associates
      • Nashville、Tennessee、アメリカ、37023
        • Tennessee Oncology, PLLC
    • Virginia
      • Richmond、Virginia、アメリカ、23235
        • Virginia Cancer Institute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

14年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Histologically-confirmed NSCLC (adenocarcinoma, large cell, and undifferentiated). Patients with squamous histology are not eligible.
  2. Life expectancy of at least 12 weeks.

  3. Patients with the following stages of NSCLC:

    • T2 N0 tumors: Limited to tumors >=4 cm.
    • T1-2 N1 tumors.
    • T3 N0-1 tumors (excluding superior sulcus tumors): Including tumors involving the chest wall, proximal airway, or mediastinal pleura where preoperative radiotherapy is not planned.
    • T1-2 N2 tumors: For patients with N2 disease involving one zone (Upper zone (R), AP zone (L), subcarinal zone, or lower zone) and nodes <=2cm in diameter.
    • T4 N0-1 tumors (excluding superior sulcus tumors): T4 lesions other than malignant effusions where radiotherapy is not planned.
  4. Patients with clinical N2 involvement must have histologic confirmation by mediastinoscopy (or alternate biopsy procedure).
  5. Tumors should be considered potentially resectable.
  6. No evidence of extrathoracic metastatic disease.
  7. Patients must have measurable disease by RECIST criteria.
  8. Patients must be candidates (medically) for chemotherapy followed by surgical resection.
  9. Adequate recovery from recent surgery. At least 1 week must have elapsed from the time of a minor surgery; at least 3 weeks must have elapsed from the time of a major surgery.

  10. Laboratory values as follows:

    • Absolute neutrophil count (ANC) >=1500/μL
    • Hemoglobin (Hgb) >=10 g/dL
    • Platelets >=100,000/uL
    • AST/SGOT and ALT/SGPT within normal limits (WNL)
    • Total bilirubin within normal limits (WNL)
    • Calculated creatinine clearance >=45 mL/min
  11. ECOG Performance Status grade 0 or 1.
  12. The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Alimta.
  13. The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
  14. Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  15. Patient must be accessible for treatment and follow-up.
  16. Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Exclusion Criteria:

  1. Patients with the following stages are excluded:

    • T1 N0;
    • T2 N0, with primary tumor <4 cm;
    • T1-2 N2, with multiple zones of N2 involvement;
    • T3-4 N2;
    • Any N3;
    • Any TxNxM1 disease; or
    • Any stage where surgery and/or chemoradiotherapy is the preferred initial approach in management, as deemed by the treating physician.
  2. Squamous or predominant squamous mixed histologies.
  3. Mixed small-cell and non-small cell histologies.
  4. Pulmonary carcinoid tumors.
  5. Presence of third space fluid which cannot be controlled by drainage.
  6. Use of erythropoietin as a hematopoietic growth factor is not allowed.
  7. Cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA) classification; unstable angina (anginal symptoms at rest) or new-onset angina (i.e., began within the last 3 months), or myocardial infarction within the past 6 months; symptomatic CHF, unstable angina pectoris, cardiac arrhythmia, or cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  8. Women who are pregnant (positive pregnancy test) or lactating.
  9. Use of any non-approved or investigational agent within 30 days of administration of the first dose of study drug.
  10. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  11. Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  12. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
  13. History of hypersensitivity to active or inactive excipients of any component of treatment.
  14. Inability to comply with study and/or follow-up procedures.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
実験的：Pemetrexed/Carboplatin

4 cycles of preoperative treatment (1 Cycle = 21 days):

Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle; Carboplatin: AUC 6.0 by IV on Day 1 each cycle.
薬：Pemetrexed
500 mg/m2 IV over 10 minutes on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
他の名前：
  • アリムタ
薬：Carboplatin
AUC 6.0 IV on Day 1 of every 3-week treatment cycle for a total of 4 cycles (12 weeks).
他の名前：
  • 41575-94-4

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
3-Year Overall Survival Rate
時間枠：36 months
The percentage of patients who were alive at 3 years from time of first study treatment until date of death from any cause. Overall survival is shown for the Intent-to-Treat population.
36 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Tumor Response
時間枠：At 6 and 12 weeks
Objective Tumor Response defined as the percent of patients who completed up to 4 cycles of pre-operative chemotherapy and achieved a complete response (CR) or partial response (PR) assessed by Response Evaluation in Solid Tumors (RECIST) 1.0. Patients with stable disease (SD) or response to treatment were deemed surgical candidates. [CR=disappearance of all target tumors; PR= ≥30% decrease in the sum of the longest diameters of target tumors. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.]
At 6 and 12 weeks
Pathologic Response Rate
時間枠：weeks 15 -18
Percent of patients having a pathological complete or partial response (pCR or pPR) at surgery. pCR defined as complete removal of all tumor. pPR defined as residual viable tumor demonstrated in the resected specimen.
weeks 15 -18
Rate of Residual Disease as an Assessment of Pathological Partial Response (pPR)
時間枠：At 15-18 weeks
pPR was further assessed by the amount of residual tumor measured at surgery: microscopic residual disease = less than 1 centimeter (<1 cm); macroscopic residual disease = 1 centimeter or greater (≥1 cm).
At 15-18 weeks
Complete Resection Rate
時間枠：At weeks 15-18
The percent of patients who had surgical resection listed by procedure type: lobectomy or pneumonectomy, or resection of adjacent chest wall or mediastinal structures when appropriate. Surgery followed standard guidelines for resection of non-small-cell lung cancer (NSCLC).
At weeks 15-18

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

SCRI Development Innovations, LLC

協力者

Eli Lilly and Company

捜査官

  • スタディチェア：David R Spigel, M.D.、SCRI Development Innovations, LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年6月1日

一次修了 (実際)

2015年8月1日

研究の完了 (実際)

2015年9月1日

試験登録日

最初に提出

2009年5月19日

QC基準を満たした最初の提出物

2009年5月20日

最初の投稿 (見積もり)

2009年5月21日

学習記録の更新

投稿された最後の更新 (実際)

2017年2月24日

QC基準を満たした最後の更新が送信されました

2017年1月5日

最終確認日

2017年1月1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

  • SCRI LUN 186

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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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