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

NCT02127372 | Terminated Phase 1 Results

• 1 other identifier: Pro00008205
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Keywords

non-small cell; lung cancer

Outcome Measures

Primary Outcomes (3)

• Phase 1 - Maximum Tolerated Dose (MTD) of STI571

  To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.

  After cycle 1, day 22

• Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin

  To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.

  After cycle 1, day 22

• Phase II - Radiographic Response

  The percentage of patients with a complete or partial response. Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

  After Cycle 6, approximately 18 weeks.

Secondary Outcomes (2)

• Phase 2: 1 Year Survival

  1 year

• Change in Gd-MRI Measurement

  Day 7

Interventions

Docetaxel, Cisplatin and STI571 DRUG

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.

Also known as: Taxotere, Platinol, Gleevec, Imatinib

Docetaxel DRUG

Also known as: Taxotere

Cisplatin DRUG

Also known as: Platinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Docetaxel; Cisplatin; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: Gordana Vlahovic, MD
• Organization: Duke University Medical Center

Gordana.vlahovic@dm.duke.edu

919-681-4047

Study Officials

• Gordana Vlahovic, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: April 30, 2014
• Study Start: November 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-09