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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

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ClinicalTrials.gov Identifier: NCT00227539
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : April 4, 2017
Last Update Posted : May 9, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Renato Martins, University of Washington

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: cisplatin
Drug: pemetrexed disodium
Procedure: adjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: fludeoxyglucose F 18
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neoadjuvant Therapy, PET Scan and Surgery
Hide Arm/Group Description

cisplatin

pemetrexed disodium

adjuvant therapy

therapeutic conventional surgery

fludeoxyglucose F 18

Period Title: Overall Study
Started 25
Completed 24
Not Completed 1
Reason Not Completed
Protocol Violation             1
Arm/Group Title Neoadjuvant Therapy, PET Scan and Surgery
Hide Arm/Group Description

cisplatin

pemetrexed disodium

adjuvant therapy

therapeutic conventional surgery

fludeoxyglucose F 18

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  64.0%
>=65 years
9
  36.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
62
(47 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
13
  52.0%
Male
12
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Hide Description Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Time Frame Between days 18 and 22 prior to second chemotherapy infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Only 19 patients had PET scans at both baseline and day 18-22 available for review.
Arm/Group Title Neoadjuvant Therapy, PET Scan and Surgery
Hide Arm/Group Description:

cisplatin

pemetrexed disodium

adjuvant therapy

therapeutic conventional surgery

fludeoxyglucose F 18

Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
11
  57.9%
2.Secondary Outcome
Title Safety of Neoadjuvant Chemotherapy
Hide Description The number of patients that experienced a grade 3 or higher adverse event.
Time Frame Up to 4 weeks after last dose of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neoadjuvant Therapy, PET Scan and Surgery
Hide Arm/Group Description:

cisplatin

pemetrexed disodium

adjuvant therapy

therapeutic conventional surgery

fludeoxyglucose F 18

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
10
  40.0%
3.Secondary Outcome
Title Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate
Hide Description 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.
Time Frame Up to 4 weeks after last dose of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Neoadjuvant Therapy, PET Scan and Surgery
Hide Arm/Group Description:

cisplatin

pemetrexed disodium

adjuvant therapy

therapeutic conventional surgery

fludeoxyglucose F 18

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
20
  95.2%
Time Frame Adverse events were collected from the time of first dose of chemotherapy through 4 weeks following the final dose of chemotherapy.
Adverse Event Reporting Description Only grade 3 and higher adverse events were collected.
 
Arm/Group Title Neoadjuvant Therapy, PET Scan and Surgery
Hide Arm/Group Description

cisplatin

pemetrexed disodium

adjuvant therapy

therapeutic conventional surgery

fludeoxyglucose F 18

All-Cause Mortality
Neoadjuvant Therapy, PET Scan and Surgery
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Neoadjuvant Therapy, PET Scan and Surgery
Affected / at Risk (%) # Events
Total   1/25 (4.00%)    
Nervous system disorders   
Stroke  1  1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neoadjuvant Therapy, PET Scan and Surgery
Affected / at Risk (%) # Events
Total   10/25 (40.00%)    
Gastrointestinal disorders   
Nausea  1  2/25 (8.00%)  25
Vomiting  1  1/25 (4.00%)  25
General disorders   
Fatigue  1  7/25 (28.00%)  25
Immune system disorders   
Drug Reaction  1  3/25 (12.00%)  25
Infections and infestations   
pneumonia  1  1/25 (4.00%)  25
Metabolism and nutrition disorders   
Hypoalbuminemia  1  1/25 (4.00%)  25
Nervous system disorders   
Pain  1  2/25 (8.00%)  25
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/25 (4.00%)  25
Pulmonary Embolism  1  1/25 (4.00%)  25
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Renato G. Martins
Organization: University of Washington
Phone: 206-288-6680
EMail: rgmart@uw.edu
Layout table for additonal information
Responsible Party: Renato Martins, University of Washington
ClinicalTrials.gov Identifier: NCT00227539    
Other Study ID Numbers: 6228
P30CA015704 ( U.S. NIH Grant/Contract )
UWCC-6228
UWCC-UW-6228
UW-04033
LILY-UW-04033
CDR0000441239 ( Registry Identifier: PDQ )
First Submitted: September 26, 2005
First Posted: September 28, 2005
Results First Submitted: February 14, 2017
Results First Posted: April 4, 2017
Last Update Posted: May 9, 2017