Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Study summary

This phase II trial is studying how well giving imatinib mesylate together with paclitaxel works in treating older patients with stage IIIB or stage IV non-small cell lung cancer. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with paclitaxel may kill more tumor cells

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedimatinib mesylate and paclitaxel

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 25, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?University of Washington

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: University of Washington
Interventions being studied: Drug: imatinib mesylate; Drug: paclitaxel

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologic or cytologic diagnosis of non-small cell lung cancer
At least one site of measurable disease, as defined by the modified RECIST criteria
Stage IIIB with pleural effusion or Stage IV disease; includes patients who received surgery alone for early stage disease, now in relapse with advanced disease; staging is according to the American Joint Committee on Cancer classification scheme, 6th edition
Total bilirubin \< 1.25 x upper limit of normal (ULN)
Baseline absolute neutrophil count \>= 1500/uL
Baseline platelet count \>= 100,000/uL
ECOG Performance Status 0, 1 or 2 at the time of informed consent
Written, voluntary consent
Patients with reproductive potential must use an acceptable contraceptive method, such methods include: 1) Male hormonal contraception; 2) Partner without reproductive potential, including post-menopausal status or history of tubal ligation; 3) Partner with intrauterine device (IUD) or contraceptive vaginal ring; 4) Partner takes oral contraceptive pill, wears contraceptive patch, or has contraceptive implant; 5) Routine use of barrier method, such as condoms or diaphragm, during sexual intercourse
AST and ALT =\< 2.5 x ULN
Creatinine =\< 1.5 x ULN

Reasons someone may not be able to joinExclusion criteria

Uncontrolled brain metastasis; patients with known brain metastasis must have completed treatment with surgery, radiation or both; in addition, they must be off corticosteroids
Symptomatic neuropathy (Grade 2 or higher)
Prior chemotherapy for advanced non-small cell lung cancer (Prior adjuvant, neoadjuvant, or chemoradiotherapy for NSCLC is permitted, provided at least 6 months elapsed prior to documented metastatic recurrence)
Patient is \< 5 years free of another primary malignancy, except: a) if the other malignancy is basal cell carcinoma or cervical carcinoma in situ or b) if the other primary malignancy is not considered clinically significant and is requiring no active intervention
Prior radiation therapy to \> 25% of bone marrow
Grade III/IV congestive heart failure, as defined by NYHA criteria, or myocardial infarction within 6 months
Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study
Patient has known chronic liver disease, e.g., diagnosis of chronic active hepatitis or cirrhosis
Major surgery two weeks prior to study treatment
Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
Any condition requiring continuous administration of systemic corticosteroids
The patient is on therapeutic anti-coagulation with warfarin
The administration of any other anticancer agents including chemotherapy and biologic agents is NOT permitted
The use of other concurrent investigational drugs is not allowed
Participants in this study must avoid grapefruit juice or other grapefruit-containing products for the duration of treatment with imatinib

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of New Mexico Cancer CenterAlbuquerque, New Mexico
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 25, 2017. Always confirm current availability with the study team.

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