Trial Outcomes & Findings for Imatinib Mesylate and Paclitaxel in Treating Older Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00408460)

Last Updated: 2017-04-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Baseline, Week 4 of courses 2, 4 and 6

Results posted on

2017-04-25

Participant Flow

Patients that were aged 70 years and above that had never received treatment for metastatic NSCLC were approached for study participation.

Participant milestones

Participant milestones
Measure	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. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Enzyme Inhibitor, Chemotherapy) n=34 Participants 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. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants
Age, Continuous	75 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4 of courses 2, 4 and 6

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor, Chemotherapy) n=34 Participants 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. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies
Overall Response Rate (Complete and Partial Responses) as Assessed by RECIST Criteria	11 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor, Chemotherapy) n=34 Participants 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. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies
Time to Tumor Progression	3.6 months Interval 0.5 to 103.0

SECONDARY outcome

Timeframe: Every 3 months for 5 years

Outcome measures

Outcome measures
Measure	Treatment (Enzyme Inhibitor, Chemotherapy) n=34 Participants 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. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies
Overall Survival	7.3 months Interval 0.5 to 60.0

Adverse Events

Treatment (Enzyme Inhibitor, Chemotherapy)

Serious events: 14 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Enzyme Inhibitor, Chemotherapy) n=34 participants at risk 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. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies
Blood and lymphatic system disorders febrile neutropenia	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Cardiac disorders cardiac arrest	8.8% 3/34 • Number of events 3 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Cardiac disorders CHF exacerbation	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Ileus	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Constipation	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Dehydration	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Diverticulitis	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Infections and infestations Infection	8.8% 3/34 • Number of events 3 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Respiratory, thoracic and mediastinal disorders pneumonitis	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Respiratory, thoracic and mediastinal disorders pneumothorax	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Renal and urinary disorders Bladder Stone	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.

Other adverse events

Other adverse events
Measure	Treatment (Enzyme Inhibitor, Chemotherapy) n=34 participants at risk 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. imatinib mesylate: Given PO paclitaxel: Given IV immunohistochemistry staining method: Optional correlative studies
Blood and lymphatic system disorders anemia	8.8% 3/34 • Number of events 3 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Blood and lymphatic system disorders leukopenia	11.8% 4/34 • Number of events 4 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Blood and lymphatic system disorders neutropenia	20.6% 7/34 • Number of events 7 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Blood and lymphatic system disorders thrombocytopenia	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Cardiac disorders Left ventricular systolic dysfunction	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
General disorders Fatigue	41.2% 14/34 • Number of events 14 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Skin and subcutaneous tissue disorders Rash	8.8% 3/34 • Number of events 3 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Dehydration	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Gastroenteritis	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Anorexia	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Constipation	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Diarrhea	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
General disorders Edema	23.5% 8/34 • Number of events 8 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Renal and urinary disorders acute kidney injury	11.8% 4/34 • Number of events 4 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Metabolism and nutrition disorders hypophosphatemia	8.8% 3/34 • Number of events 3 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Nervous system disorders Foot Drop	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Nervous system disorders Neuropathy	29.4% 10/34 • Number of events 10 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Nervous system disorders Syncope	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Gastrointestinal disorders Mucositis	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Nervous system disorders increased pain	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Respiratory, thoracic and mediastinal disorders pleural effusion	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Respiratory, thoracic and mediastinal disorders pneumonia	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Respiratory, thoracic and mediastinal disorders pulmonary edema	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Renal and urinary disorders Kidney stone	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.
Renal and urinary disorders Urinary tract infection	2.9% 1/34 • Number of events 1 • Adverse events were collected from the first dose of imatinib mesylate through to the last dose of imatinib mesylate, an average of 6 months. Only grade 3 and higher adverse events were collected with the following exceptions. Any grade neuropathy or edema and any other adverse event that required a dose reduction or dose delay.

Additional Information

Renato G Martins, MD

University of Washington

Phone: 206-288-2048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place