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

Duke University

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Docetaxel

Drug: Docetaxel, Cisplatin and STI571

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT02127372

Pro00008205

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.