Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Primary Purpose
Malignant Pleural Effusion, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
imatinib mesylate
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Effusion
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
Sites / Locations
- University of New Mexico Cancer Center
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment (enzyme inhibitor, chemotherapy)
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Secondary Outcome Measures
Time to Tumor Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Overall Survival
Full Information
NCT ID
NCT00408460
First Posted
December 6, 2006
Last Updated
March 13, 2017
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00408460
Brief Title
Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Official Title
A Phase II Study of Intermittent Gleevec® (Imatinib Mesylate) and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion, Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (enzyme inhibitor, chemotherapy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
imatinib mesylate
Other Intervention Name(s)
CGP 57148, Gleevec, Glivec
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
Baseline, Week 4 of courses 2, 4 and 6
Secondary Outcome Measure Information:
Title
Time to Tumor Progression
Description
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame
Baseline and every 2 months post treatment until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed up to 5 years.
Title
Overall Survival
Time Frame
Every 3 months for 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Martins
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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