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

This study has been terminated.
(Stopped early due to low enrollment)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00356525
First received: July 24, 2006
Last updated: August 9, 2010
Last verified: August 2010

July 24, 2006
August 9, 2010
September 2006
June 2008   (final data collection date for primary outcome measure)
Objective Tumor Response [ Time Frame: baseline to time of response (up to 17.5 months) ] [ Designated as safety issue: No ]
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.
To observe the objective tumor response rate for four groups of patients.
Complete list of historical versions of study NCT00356525 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: baseline to trial termination (17.5 months) ] [ Designated as safety issue: No ]
    Overall survival is the number of participants who were alive when the trial was terminated.
  • Time to Progressive Disease [ Time Frame: baseline to measured progressive disease (up to 17.5 months) ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: time of response to progressive disease (up to 17.5 months) ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: baseline to stopping treatment (up to 17.5 months) ] [ Designated as safety issue: Yes ]
To observe time to event variables including progression free survival, time to disease progression, duration of response, time to treatment failure, one year survival, and toxicities.
Not Provided
Not Provided
 
Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Neoplasms
  • Drug: pemetrexed
    500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
    Other Names:
    • LY231514
    • Alimta
  • Drug: gemcitabine
    1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression
    Other Names:
    • LY188011
    • Gemzar
  • Drug: carboplatin
    area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
  • Drug: Pemetrexed
    500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
    Other Names:
    • LY231514
    • Alimta
  • Experimental: Less Than One Year: Pemetrexed
    Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
    Interventions:
    • Drug: pemetrexed
    • Drug: gemcitabine
  • Experimental: Less Than One Year: Pemetrexed + Gemcitabine
    Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
    Intervention: Drug: Pemetrexed
  • Experimental: One Year or Greater: Pemetrexed + Carboplatin
    Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
    Interventions:
    • Drug: carboplatin
    • Drug: Pemetrexed
  • Experimental: One Year or Greater: Pemetrexed + Gemcitabine
    Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
    Interventions:
    • Drug: pemetrexed
    • Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
41
April 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Brazil
 
NCT00356525
9934, H3E-US-S082
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP