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

Primary Purpose

Non-small Cell Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Docetaxel, Cisplatin and STI571

Docetaxel

Cisplatin

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring non-small cell, lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Phase 2: 1 Year Survival

Phase II: Percentage of patients alive 1 year from the start of protocol treatment.

Change in Gd-MRI Measurement

The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.

Full Information

NCT ID

NCT02127372

First Posted

April 24, 2014

Last Updated

September 12, 2014

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02127372

Brief Title

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

Official Title

A Phase I - II Open Label Study of the Maximum Tolerated Dose, Safety and Efficacy of Docetaxel and Cisplatin Plus STI571 in Advanced Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Terminated

Why Stopped

The study was closed due to poor accrual

Study Start Date

November 2004 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

non-small cell, lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Docetaxel, Cisplatin and STI571

Other Intervention Name(s)

Taxotere, Platinol, Gleevec, Imatinib

Intervention Description

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

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol

Primary Outcome Measure Information:

Title

Phase 1 - Maximum Tolerated Dose (MTD) of STI571

Description

Time Frame

After cycle 1, day 22

Title

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

Description

Time Frame

After cycle 1, day 22

Title

Phase II - Radiographic Response

Description

Time Frame

After Cycle 6, approximately 18 weeks.

Secondary Outcome Measure Information:

Title

Phase 2: 1 Year Survival

Description

Phase II: Percentage of patients alive 1 year from the start of protocol treatment.

Time Frame

1 year

Title

Change in Gd-MRI Measurement

Description

The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.

Time Frame

Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gordana Vlahovic, MD, MHS

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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