Status:
COMPLETED
Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Pleural Effusion
Recurrent Non-small Cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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 ma...
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 OBJ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00408460
Start Date
February 1 2006
End Date
October 1 2012
Last Update
April 25 2017
Active Locations (2)
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1
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
2
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109