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Maximum Tolerated Dose, Safety and Efficacy of Docetaxel / Cisplatin + STI571

NCT02127372 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-09-15

Study results available
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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.

Conditions

Interventions

DRUG

Docetaxel, Cisplatin and STI571

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.

DRUG

Docetaxel

DRUG

Cisplatin

Sponsors & Collaborators

Principal Investigators

  • Gordana Vlahovic, MD, MHS · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2010-06-30
Completion
2010-12-31

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Entities

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02127372 on ClinicalTrials.gov