Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

August 9, 2010 updated by: Eli Lilly and Company

Phase II, Randomized, Open-Label Trial of Biweekly Pemetrexed Plus Gemcitabine vs. Pemetrexed or Pemetrexed Plus Carboplatin in Relapsed Non Small Cell Lung Cancer After Neoadjuvant or Adjuvant Chemotherapy

The purpose of this study is to help answer:

  • Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
  • Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Caxias Do Sul, Brazil, 95070560
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Porto Alegre, Brazil, 90430-090
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Santo Andre, Brazil, 09090780
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • India
      • Bangalore, India, 560 029
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mumbai, India, 400016
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Trivandrum, India, 695011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • United States
    • Florida
      • Miami, Florida, United States, 33179
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Evanston, Illinois, United States, 60201
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kansas
      • Wichita, Kansas, United States, 67214
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Memphis, Tennessee, United States, 38120
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nashville, Tennessee, United States, 37203
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Houston, Texas, United States, 77060
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.
  • You have good kidney, liver, and bone marrow organ function.
  • You are fully active or able to carry out light work such as housework or office work.

Exclusion Criteria:

  • You have received pemetrexed or gemcitabine in the past for lung cancer
  • You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past
  • You are unable to take corticosteroid drugs like dexamethasone
  • You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study
  • You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study
  • You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Less Than One Year: Pemetrexed
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • Alimta
  • LY231514
Drug: gemcitabine
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • Gemzar
  • LY188011
Experimental: Less Than One Year: Pemetrexed + Gemcitabine
Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Other Names:
  • Alimta
  • LY231514
Experimental: One Year or Greater: Pemetrexed + Carboplatin
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
Other Names:
  • Alimta
  • LY231514
Drug: carboplatin
area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
Experimental: One Year or Greater: Pemetrexed + Gemcitabine
Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • Alimta
  • LY231514
Drug: gemcitabine
1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
Other Names:
  • Gemzar
  • LY188011

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Tumor Response
Time Frame: baseline to time of response (up to 17.5 months)
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
baseline to time of response (up to 17.5 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: baseline to trial termination (17.5 months)
Overall survival is the number of participants who were alive when the trial was terminated.
baseline to trial termination (17.5 months)
Time to Progressive Disease
Time Frame: baseline to measured progressive disease (up to 17.5 months)
baseline to measured progressive disease (up to 17.5 months)
Duration of Response
Time Frame: time of response to progressive disease (up to 17.5 months)
time of response to progressive disease (up to 17.5 months)
Time to Treatment Failure
Time Frame: baseline to stopping treatment (up to 17.5 months)
baseline to stopping treatment (up to 17.5 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

July 24, 2006

First Submitted That Met QC Criteria

July 24, 2006

First Posted (Estimate)

July 26, 2006

Study Record Updates

Last Update Posted (Estimate)

August 17, 2010

Last Update Submitted That Met QC Criteria

August 9, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9934
  • H3E-US-S082 (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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