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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02127372
• Other study ID #: Pro00008205
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: April 24, 2014
• Last updated: September 12, 2014
• Start date: November 2004
• Est. completion date: December 2010

Study information

• Verified date: September 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.
• Docetaxel

• Cisplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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.	No
Secondary	Phase 2: 1 Year Survival	Phase II: Percentage of patients alive 1 year from the start of protocol treatment.	1 year	No
Secondary	Change in Gd-MRI Measurement	The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.	Day 7	No