Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 43
Healthy volunteers: no

Brief summary:
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).

This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.

Detailed description:

Arms:

Interventions: intervention 1: Docetaxel, Cisplatin and STI571 intervention 2: Docetaxel intervention 3: Cisplatin
Intervention descriptions: intervention 1: Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given.

Phase 1 dose levels are:

* Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg
* Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg
* Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg
* Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg
* Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg
* Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg

Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II. intervention 2: None intervention 3: None

Protocol document: