Efficacy/Safety of Imprime PGG With Cetuximab & Paclitaxel/Carboplatin Therapy in Pts With Untreated Advanced Non-Small Cell Lung Cancer
Efficacy and Safety Study of Imprime PGG® Injection in Combination With Cetuximab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer
調査の概要
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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Georgia
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Augusta、Georgia、アメリカ、30912
- Medical College of Georgia
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Indiana
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Terre Haute、Indiana、アメリカ、47802
- Providence Medical Group
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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Texas
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Dallas、Texas、アメリカ、75201
- Mary Crowley Medical Research Center
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Midland、Texas、アメリカ、79701
- Allison Cancer Center
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Berlin、ドイツ
- Helios Clinic Emil von Behring
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Frankfurt、ドイツ
- Municipal Clinic Frankfurt Hoescht
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Gottingen、ドイツ、37075
- Georg-August University Göttingen
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Heidelberg、ドイツ
- University Clinical Heidelberg
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Minden、ドイツ
- Clinic Minden
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Munich、ドイツ
- Techincal University of Munich
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Nuremberg、ドイツ
- Clinic Nurnberg Nord
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Ulm、ドイツ、89081
- Universitätsklinikum Ulm
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Wuppertal、ドイツ、42283
- HELIOS Klinikum Wuppertal, Medizinische Klinik 1
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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:
- Has read, understood and signed the informed consent form (ICF) approved by the Independent Review Board/Ethics Committee (IRB/EC)
- Is between the ages of 18 and 75 years old, inclusive
- Has histologically or cytologically confirmed stage IIIB (malignant pericardial or pleural effusion) or stage IV non-small cell lung cancer
- Has measurable disease, defined as at least one tumor that fulfills the criteria for a target lesion according to RECIST
- Has an ECOG performance status of 0 or 1
- Has a life expectancy of > 3 months
Has adequate hematologic function as evidenced by:
- ANC ≥ 1,500/μL
- PLT ≥ 100,000/μL
- HGB ≥ 9 g/dL obtained within 1 week prior to the first dose of study medication;
Has adequate renal function as evidenced by:
- Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) for the reference lab
- Urine dipstick for proteinuria of < 1+ (i.e., either 0 or trace) within 2 weeks of Day 1 If urine dipstick is ≥ 1+, then urine protein excretion must be ≤ 500 mg over a 24 hour collection obtained within 1 week prior to the first dose of study medication;
Has adequate hepatic function as evidenced by:
- Serum total bilirubin ≤ 1.0 mg/dL
- AST ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases)
- ALT ≤ 2.5X ULN for the reference lab (≤ 5X ULN for subjects with known hepatic metastases) obtained within 1 week prior to the first dose of study medication;
- If a woman of childbearing potential or a fertile man (and his partners), must agree to use an effective form of contraception (hormonal contraceptive, double-barrier method or abstinence) during the study.
Exclusion Criteria:
- Has received prior systemic chemotherapy at any time for lung cancer;
- Has received previous radiation therapy to >30% of active bone marrow or any radiation therapy within 3 weeks of Day 1
- Has a known hypersensitivity to baker's yeast, or has an active yeast infection
- Has had previous exposure to Betafectin® or Imprime PGG
- Has an active infection
Presents with any of the following medical diagnoses/conditions at the time of screening:
- Central nervous system (CNS) metastases
- Uncontrolled hypertension (>150/100 mmHg) or hypertension that requires > two agents for adequate control
- Peripheral neuropathy ≥ grade 2 from any cause
- Fever of >38.5° C within 3 days prior to screening or Day 1, initial dosing
- Known HIV/AIDs, Hepatitis B, Hepatitis C, connective tissue or autoimmune disease, or other clinical diagnosis, ongoing or intercurrent illness that in the physician's opinion could interfere with participation
Has a history of any of the following medical diagnoses/conditions:
- Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure) within the previous 6 months
- Second malignancy within the previous 5 years, other than basal cell carcinoma, cervical intra-epithelial neoplasia or curatively treated prostate cancer with a PSA of <2.0 ng/mL
- Has a known hypersensitivity to cetuximab, murine proteins, or any component of cetuximab
- Has a know sensitivity to Cremophor EL
- Has previously received treatment with cetuximab
- If female, is pregnant or breast-feeding
- Is receiving concurrent investigational therapy or has received investigational therapy within a period of 30 days prior to the first scheduled day of dosing (investigational therapy is defined as treatment for which there is currently no regulatory-authority-approved indication)
- Has previously received an organ or progenitor/stem cell transplant.
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
- 介入モデル：並列代入
- 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：Imprime PGG
Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
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4 mg/kg i.v. over 2 hrs, weekly, in three week cycles
initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
他の名前：
200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
他の名前：
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
他の名前：
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アクティブコンパレータ：Control
Cetuximab + Paclitaxel/Carboplatin
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initial loading dose of 400 mg/m^2 over 120 min and subsequent doses at 250 mg/m^2 over 60 min, weekly on Days 1, 8 and 15 of each 3-week treatment cycle
他の名前：
200 mg/m^2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
他の名前：
dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles
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 |
|---|---|---|
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Objective Response Rate (ORR) in Each Study Arm Based on Independent Central Radiology Review
時間枠：From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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Overall objective response rate was defined as the number of participants experiencing a best overall response of either complete response (CR) or partial response (PR) based on the modified RECIST v1.0 criteria. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. |
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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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 |
|---|---|---|
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Overall Survival (OS) in Each Study Arm Based on the Safety Population
時間枠：From the time of randomization to death, subject being lost to follow-up or study completion
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Overall survival (OS) was defined as the time from the date of randomization until the date of documented death of the subject due to any cause, including death due to relapses that were successfully retreated.
Subjects who were lost to follow-up or who were still alive at the time of analysis were censored at the last contact dates.
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From the time of randomization to death, subject being lost to follow-up or study completion
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Disease Control Rate (DCR) in Each Study Arm Based on Independent Central Radiology Review
時間枠：From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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The disease control rate (DCR) was defined as the number of participants experiencing a best overall tumor response of either CR, PR or SD. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. |
From first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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Complete Response (CR), Partial Response (PR), and Stable Disease (SD) Rates in Each Study Arm Based on Independent Central Radiology Review
時間枠：From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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The best observed overall response rates were defined as the number of participants experiencing a best overall response of either complete response (CR), partial response (PR) or stable disease (SD) based on the modified RECIST v1.0 criteria. For stable disease (SD), follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. |
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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Duration of Objective Tumor Response in Each Study Arm Based on Independent Central Radiology Review
時間枠：From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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The duration of objective tumor response was measured from the time at which criteria are met for CR or PR (whichever status is recorded first) until the first date on which recurrence or progressive disease is objectively documented per modified RECIST v1.0. Subjects who did not progress as of the data cutoff date were censored at their last tumor assessment date. The analysis performed for this study utilized a modified RECIST v1.0 in which a confirmed response after the initial response assessment was not required by repeat assessment. With the use of centrally read, blinded radiological assessments performed by independent radiologists, and the use of randomization between study arms, the criterion requiring a 'confirmation' response was removed. All other RECIST v1.0 criteria remained unmodified and implemented as stated in the guidelines. |
From the first dose to disease progression or last tumor assessment before treatment discontinuation due to any reason, up to 15 months
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Duration of Time to Progression (TTP) in Each Study Arm Based on Independent Central Radiology Review
時間枠：From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months
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Time-to-progression (TTP) was defined as the time from the date of randomization to the first date of documented progressive disease. Progressive disease was identified by radiologic progressive disease according to modified RECIST v1.0, or in the case of the Investigator Radiologic Review, it may also be defined by clinical progression as determined by the investigator. If a subject received any further anti-cancer therapy without prior documentation of disease progression, the subject was censored at the date of last tumor assessment before starting anti-cancer treatment. Subjects who died on study from other causes (not related to study disease) and subjects who were lost to follow-up or who were alive without documented progressive disease as of the data cut-off date for analysis were censored at the last tumor assessment date. |
From time of randomization to first date of documented progression, or last tumor assessment date, up to 15 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Folker Schneller, MD、Technical University, Munich
出版物と役立つリンク
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
- BT-CL-PGG-LCA0822
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?
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