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

NCT ID: NCT00408460

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2012-10-31

Brief 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

Detailed Description

PRIMARY OBJECTIVES:

I. To estimate the clinical efficacy of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer.

SECONDARY OBJECTIVES:

I. To evaluate the safety profile of the combination of weekly paclitaxel and intermittent imatinib in elderly patients with advanced non-small cell lung cancer.

II. To collect paraffin tissue blocks for a companion project evaluating the expression of platelet derived growth factor (PDGF) by original tumor specimens, and its relationship to response rate and survival.

OUTLINE:

Patients receive paclitaxel intravenously (IV) on days 3, 10, and 17 and imatinib mesylate orally (PO) once daily (QD) on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Conditions

Malignant Pleural Effusion; Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (enzyme inhibitor, chemotherapy)

Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Given PO

paclitaxel

Intervention Type: DRUG

Given IV

Interventions

imatinib mesylate

Given PO

Intervention Type: DRUG

paclitaxel

Given IV

Intervention Type: DRUG

Other Intervention Names

CGP 57148; Gleevec; Glivec; Anzatax; Asotax; TAX; Taxol

Eligibility Criteria

Inclusion 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

Exclusion 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Renato Martins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renato Martins

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2010-00420

Identifier Type: REGISTRY

Identifier Source: secondary_id

6137

Identifier Type: -

Identifier Source: org_study_id