A Randomized, Phase III Trial of ABI-007 and Carboplatin Compared With Taxol and Carboplatin as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 1,052
- 试验地点
- 37
- 主要终点
- Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment
研究概览
简要总结
The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC)
- •Male or non-pregnant and non-lactating female, and equal or greater than age 18
- •If a female patient is of child-bearing potential, as evidence by regular menstrual periods, she must have a negative serum pregnancy test (beta human chorionic gonadotropin [βhCG]) documented within 72 hours of the first administration of study drug
- •If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator
- •No other current active malignancy
- •Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion)
- •Patients must have received no prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study
- •Patient has the following blood counts at baseline:
- •Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L
- •Platelets greater than or equal to 100x10^9/L
- •Hemoglobin (Hgb) greater than or equal to 9 g/dL
- •Patient has the following blood chemistry levels at baseline:
- •Aspartate aminotransferase (SGOT), alanine aminotransferase (SGPT) less than or equal to 2.5 x upper limit of normal range (ULN) or less than or equal to 5.0 x ULN if liver metastases;
- •Total bilirubin less than or equal to ULN
- •Creatinine less than or equal to 1.5 mg/dL
- •Expected survival of greater than 12 weeks
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities
排除标准
- •Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable and off therapy for greater than or equal to 1 month
- •The only evidence of disease is non-measurable
- •Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events [CTCAE] Version 3).
- •Patient received radiotherapy in the last 4 weeks, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed
- •Patient has a clinically significant concurrent illness
- •Patient has received treatment with any investigational drug within the previous 4 weeks
- •Patient has a history of allergy or hypersensitivity to any of the study drugs
- •Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug
- •Patient is enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices.
研究组 & 干预措施
Albumin-bound paclitaxel + Carboplatin
Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
干预措施: Albumin-bound paclitaxel (Drug)
Albumin-bound paclitaxel + Carboplatin
Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
干预措施: Carboplatin (Drug)
Paclitaxel + Carboplatin
Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21 day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
干预措施: Paclitaxel (Drug)
Paclitaxel + Carboplatin
Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21 day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved an Objective Confirmed Complete Response or Partial Response by Blinded Radiology Assessment
时间窗: Objective response was evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesions and no new lesions. Partial response was defined as ≥ 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD, and the persistence of one or more non-target lesions not qualifying for CR or Progressive Disease (the "unequivocal progression" of existing non-target lesion(s) or appearance of one or more new lesions).
次要结局
- Progression-free Survival by Blinded Radiology Assessment(Assessed every 6 weeks until progression or death, up to 38 months)
- Overall Participant Survival(Up to 38 months)
- Percentage of Participants With Controlled Disease(Assessed every 6 weeks, up to 22 months)
- Duration of Response in Responding Patients(Assessed every 6 weeks, up to 38 months)
- Number of Participants With Adverse Events (AEs)(Up to 38 months)
- Pharmacokinetic (PK) Parameters(Blood samples for PK analyses were taken during Cycle 1 at 0.25, 3.5 and 24 hours post-infusion.)
- SPARC Status and Correlation With Overall Survival(Archival tissue samples were used for SPARC analysis. Survival was assessed for up to 38 months.)