Trial Outcomes & Findings for Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer (NCT NCT00227539)

NCT ID: NCT00227539

Last Updated: 2017-05-09

Results Overview

Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: Between days 18 and 22 prior to second chemotherapy infusion
• Results posted on: 2017-05-09

Participant Flow

Participant milestones

Measure	Neoadjuvant Therapy, PET Scan and Surgery cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Neoadjuvant Therapy, PET Scan and Surgery cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Overall Study Protocol Violation	1

Baseline Characteristics

Positron Emission Tomography in Predicting Response in Patients Who Are Undergoing Treatment With Pemetrexed Disodium and Cisplatin With or Without Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Neoadjuvant Therapy, PET Scan and Surgery n=25 Participants cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Between days 18 and 22 prior to second chemotherapy infusion

Population: Only 19 patients had PET scans at both baseline and day 18-22 available for review.

Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy

Outcome measures

Measure	Neoadjuvant Therapy, PET Scan and Surgery n=19 Participants cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy	11 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks after last dose of chemotherapy

The number of patients that experienced a grade 3 or higher adverse event.

Outcome measures

Measure	Neoadjuvant Therapy, PET Scan and Surgery n=25 Participants cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Safety of Neoadjuvant Chemotherapy	10 Participants

SECONDARY outcome

Timeframe: Up to 4 weeks after last dose of chemotherapy

Population: One patient was excluded from the efficacy analysis because they were subsequently found to be ineligible. Three patients were unevaluable because they did not have have a CT scan after the completion of chemotherapy.

The number of patients that had either a CR, PR or SD after the completion of chemotherapy. 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; Progression, 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.

Outcome measures

Measure	Neoadjuvant Therapy, PET Scan and Surgery n=21 Participants cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate	20 Participants

Adverse Events

Neoadjuvant Therapy, PET Scan and Surgery

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Neoadjuvant Therapy, PET Scan and Surgery n=25 participants at risk cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Nervous system disorders Stroke	4.0% 1/25 • Number of events 1 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.

Other adverse events

Measure	Neoadjuvant Therapy, PET Scan and Surgery n=25 participants at risk cisplatin pemetrexed disodium adjuvant therapy therapeutic conventional surgery fludeoxyglucose F 18
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 1/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
General disorders Fatigue	28.0% 7/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
Immune system disorders Drug Reaction	12.0% 3/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
Metabolism and nutrition disorders Hypoalbuminemia	4.0% 1/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
Nervous system disorders Pain	8.0% 2/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
Gastrointestinal disorders Nausea	8.0% 2/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
Infections and infestations pneumonia	4.0% 1/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	4.0% 1/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 25 • Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy. Only grade 3 and higher adverse events were collected.

Additional Information

Renato G. Martins

University of Washington

Phone: 206-288-6680

Email: rgmart@uw.edu

Results disclosure agreements

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