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

NCT ID: NCT02127372

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Docetaxel

Intervention Type: DRUG

Cisplatin

Intervention Type: DRUG

Other Intervention Names

Taxotere; Platinol; Gleevec; Imatinib; Taxotere; Platinol

Eligibility Criteria

Inclusion Criteria

• Patients must have histologically or cytologically recurrent, or advanced NSCLC: Stage IV disease; or Stage IIIB due to malignant pleural effusion is allowed- only if successfully pleurodesed.
• Tumor tissue slides must express phosophorylated pdgf-rB by IHC.
• At least one measurable target lesion as defined by RECIST criteria that has not been irradiated.
• No prior chemotherapy treatment for this disease will be allowed. Patients with brain metastasis will have to be, after appropriate treatment, neurologically stable for at least 1-2 weeks (off steroids) prior to study enrollment.
• ECOG performance status 0-1.
• Meets initial laboratory parameters.
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria

• Any prior treatment with a biologic response modifier or chemotherapeutic agent for this disease.
• Any concomitant malignancy except non-melanoma skin cancer or in-situ carcinoma of the cervix.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to STI571 and/or docetaxel, or other drugs formulated with polysorbate 80 and/or cisplatin.
• Patients with:

• Contrast allergy.
• GI bleed ≤ 1 month from study enrollment.
• Intermittent or chronic oxygen requirements.
• Pulse oximetry <90%.
• Grade 3 dyspnea.
• History of poorly regulated anticoagulation with warfarin.
• Edema or fluid retention grade >1.
• Neuropathy grade ≥1.
• Uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, ≤3 months myocardial infarction or cardiac arrhythmia.
• Psychiatric illness/social situations that would limit compliance with study requirement or that would prevent informed consent or psychiatric illness/social situations requiring inpatient treatment within the past 3 months.
• Any type of hearing impairment.
• Known HIV infection.
• Receiving other investigational agents.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gordana Vlahovic, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00008205

Identifier Type: -

Identifier Source: org_study_id