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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 24, 2006

Last Updated Date

August 9, 2010

Start Date ^ICMJE

September 2006

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

To observe the objective tumor response rate for four groups of patients.

Change History

Complete list of historical versions of study NCT00356525 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Lung Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, India

Administrative Information

NCT Number ^ICMJE

NCT00356525

Other Study ID Numbers ^ICMJE

9934, H3E-US-S082

Has Data Monitoring Committee

Responsible Party

Chief Medical Officer, Eli Lilly

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

August 2010

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

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