Clinical trial NCT02127372: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell
lung cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Phase 1 - Maximum Tolerated Dose (MTD) of STI571
timeFrame: After cycle 1, day 22
measure: Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin
timeFrame: After cycle 1, day 22
measure: Phase II - Radiographic Response
timeFrame: After Cycle 6, approximately 18 weeks.
Secondary outcomes:
measure: Phase 2: 1 Year Survival
timeFrame: 1 year
measure: Change in Gd-MRI Measurement
timeFrame: Day 7
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Gordana Vlahovic, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: