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Pemetrexed Disodium and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00248495
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : May 19, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: 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: conventional surgery
Procedure: neoadjuvant therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Neoadjuvant Chemotherapy

Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses

cisplatin: Given IV

pemetrexed disodium: Given IV

adjuvant therapy: Metastasis prevention/control

conventional surgery: Undergoing tissue removal

neoadjuvant therapy: Tumor Reduction


Participant Flow:   Overall Study
    Neoadjuvant Chemotherapy
STARTED   38 
COMPLETED   37 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All treated and eligible patients

Reporting Groups
  Description
Neoadjuvant Chemotherapy

Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses

cisplatin: Given IV

pemetrexed disodium: Given IV

adjuvant therapy: Metastasis prevention/control

conventional surgery: Undergoing tissue removal

neoadjuvant therapy: Tumor Reduction


Baseline Measures
   Neoadjuvant Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 38 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.8  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      19  50.0% 
Male      19  50.0% 


  Outcome Measures

1.  Primary:   Pathologically Complete Response   [ Time Frame: 1 year ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 1 year ]

3.  Secondary:   Overall Survival   [ Time Frame: Every 6 months until the time of death up to 126 months ]

4.  Secondary:   Disease Free Survival   [ Time Frame: At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months ]

5.  Secondary:   Correlation Between Response and Markers Such as Presence or Absence of ERCC1 and DHFR, TS, DPD and GARFT   [ Time Frame: 1 year ]

6.  Secondary:   Percent Change in SUV Level Between Pre and Post Chemotherapy   [ Time Frame: Baseline and post-chemotherapy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00248495     History of Changes
Obsolete Identifiers: NCT01731626
Other Study ID Numbers: CDR0000441025
RPCI I-31104
First Submitted: November 3, 2005
First Posted: November 4, 2005
Results First Submitted: April 10, 2017
Results First Posted: May 19, 2017
Last Update Posted: July 12, 2017