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临床试验/NCT00016315
NCT00016315已完成1 期

A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients With Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Radiation Therapy Oncology Group19 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2001年5月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
35
试验地点
19
主要终点
To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.

详细描述

OBJECTIVES:

  • Determine the maximum tolerated dose (MTD) of gemcitabine when administered with carboplatin and thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in patients with stage IIIA or IIIB non-small cell lung cancer.
  • Determine the MTD of gemcitabine and paclitaxel when administered with thoracic radiotherapy followed by adjuvant gemcitabine and carboplatin in these patients.

OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens.

  • Regimen A: Patients receive gemcitabine IV over 30-60 minutes on days 1, 8, 22, 29, and 43 and thoracic radiotherapy daily 5 days a week for 7 weeks beginning on day 1.
  • Regimen B (closed to accrual as of 5/13/03): Patients receive gemcitabine and thoracic radiotherapy as in regimen A and carboplatin IV over 30 minutes on days 1, 8, 22, 29, and 43.
  • Regimen C: Patients receive gemcitabine and thoracic radiotherapy as in regimen A and paclitaxel IV over 1 hour on days 1, 8, 22, 29, and 43.

At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days 71 and 92.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 9

Experimental

Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: carboplatin (Drug)

Arm 1

Experimental

Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT)

干预措施: gemcitabine hydrochloride (Drug)

Arm 1

Experimental

Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT)

干预措施: radiation therapy (Radiation)

Arm 2

Experimental

Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 2

Experimental

Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

干预措施: paclitaxel (Drug)

Arm 2

Experimental

Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

干预措施: radiation therapy (Radiation)

Arm 3

Experimental

Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: carboplatin (Drug)

Arm 3

Experimental

Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 3

Experimental

Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: radiation therapy (Radiation)

Arm 4

Experimental

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 4

Experimental

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

干预措施: paclitaxel (Drug)

Arm 4

Experimental

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT

干预措施: radiation therapy (Radiation)

Arm 6

Experimental

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 6

Experimental

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

干预措施: paclitaxel (Drug)

Arm 6

Experimental

Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

干预措施: radiation therapy (Radiation)

Arm 8

Experimental

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 8

Experimental

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

干预措施: paclitaxel (Drug)

Arm 12

Experimental

Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: paclitaxel (Drug)

Arm 8

Experimental

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT

干预措施: radiation therapy (Radiation)

Arm 10

Experimental

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 10

Experimental

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: paclitaxel (Drug)

Arm 10

Experimental

Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: radiation therapy (Radiation)

Arm 12

Experimental

Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 12

Experimental

Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: radiation therapy (Radiation)

Arm 14

Experimental

Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 14

Experimental

Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: paclitaxel (Drug)

Arm 14

Experimental

Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT

干预措施: radiation therapy (Radiation)

Arm 5

Experimental

Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: carboplatin (Drug)

Arm 5

Experimental

Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 5

Experimental

Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: radiation therapy (Radiation)

Arm 7

Experimental

Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: carboplatin (Drug)

Arm 7

Experimental

Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 7

Experimental

Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: radiation therapy (Radiation)

Arm 9

Experimental

Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 9

Experimental

Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: radiation therapy (Radiation)

Arm 11

Experimental

Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: carboplatin (Drug)

Arm 11

Experimental

Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: gemcitabine hydrochloride (Drug)

Arm 11

Experimental

Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT

干预措施: radiation therapy (Radiation)

结局指标

主要结局

To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy

时间窗: From start of treatment to 90 days

To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy

时间窗: From start of treatment to 90 days

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (19)

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