Trial Outcomes & Findings for Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer (NCT NCT01011075)

NCT ID: NCT01011075

Last Updated: 2015-07-03

Results Overview

Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2015-07-03

Participant Flow

Subject screening for this study began effective 08/12/2009 at the UNM Cancer Center. Recruitment was conducted through the outpatient clinic. Patients were recruited until 04/30/2010.

Participant milestones

Measure	Imatinib Mesylate and Paclitaxel Experimental: 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.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Gleevec and Weekly Paclitaxel in Patients Aged 70 or Older With Advanced Non-small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Imatinib Mesylate and Paclitaxel n=34 Participants Experimental: 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.
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	74.5 years STANDARD_DEVIATION 4.6 • 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: 6 months

Population: 6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.

Response rates according to RECIST criteria (version 1.0) expressed as percentage of evaluable patients.

Outcome measures

Measure	Imatinib Mesylate and Paclitaxel n=28 Participants Experimental: 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.
Response Rate	32 Percentage of Participants Interval 17.4 to 50.5

SECONDARY outcome

Timeframe: 12 Months

Population: 6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.

Overall survival as measured by the Kaplan-Meier method

Outcome measures

Measure	Imatinib Mesylate and Paclitaxel n=28 Participants Experimental: 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.
Overall Survival	7.3 Months Interval 5.0 to 16.0

SECONDARY outcome

Timeframe: 12 months

Population: 6 of the enrolled 34 patients were inevaluable for the primary endpoint of Response Rate due to withdrawal or death prior to first response assessment.

Number of months post treatment without measurable progression according to RECIST criteria (version 1.0)

Outcome measures

Measure	Imatinib Mesylate and Paclitaxel n=28 Participants Experimental: 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.
Progression Free Survival	3.6 Months Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 12 months

Population: All enrolled and treated patients were evaluated for grade 3 or higher toxicities.

Adverse events of grade 3 or higher, according to CTCAE version 3

Outcome measures

Measure	Imatinib Mesylate and Paclitaxel n=34 Participants Experimental: 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.
Toxicities	34 Number of events

Adverse Events

Imatinib Mesylate and Paclitaxel

Serious events: 4 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Imatinib Mesylate and Paclitaxel n=34 participants at risk Experimental: 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.
Cardiac disorders Cardiac arrest	2.9% 1/34 • Number of events 1 • 1 year
Cardiac disorders Myocardial infarction	2.9% 1/34 • Number of events 1 • 1 year
Infections and infestations Infection	2.9% 1/34 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.9% 1/34 • Number of events 1 • 1 year

Other adverse events

Measure	Imatinib Mesylate and Paclitaxel n=34 participants at risk Experimental: 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.
Blood and lymphatic system disorders Anemia	2.9% 1/34 • Number of events 1 • 1 year
Blood and lymphatic system disorders Neutropenia	14.7% 5/34 • 1 year
Blood and lymphatic system disorders Febrile Neutropenia	2.9% 1/34 • 1 year
Cardiac disorders Systolic dysfunction	5.9% 2/34 • 1 year
Blood and lymphatic system disorders Edema	2.9% 1/34 • 1 year
General disorders Fatigue	29.4% 10/34 • 1 year
Infections and infestations Infection	11.8% 4/34 • 1 year
Gastrointestinal disorders Constipation	5.9% 2/34 • 1 year
Gastrointestinal disorders Diarrhea	5.9% 2/34 • 1 year
Respiratory, thoracic and mediastinal disorders Embolism	2.9% 1/34 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.9% 1/34 • 1 year
Renal and urinary disorders Bladder/Kidney stone	5.9% 2/34 • 1 year

Additional Information

Julie E. Bauman, MD

University of Pittsburgh Cancer Institute

Phone: 412-648-6507

Email: baumanje@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60