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

Phase 2

Terminated

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Less Than One Year: Pemetrexed + Gemcitabine	Pemetrexed	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
Less Than One Year: Pemetrexed	Pemetrexed	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
Less Than One Year: Pemetrexed	gemcitabine	Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy
One Year or Greater: Pemetrexed + Carboplatin	carboplatin	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
One Year or Greater: Pemetrexed + Carboplatin	Pemetrexed	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
One Year or Greater: Pemetrexed + Gemcitabine	Pemetrexed	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
One Year or Greater: Pemetrexed + Gemcitabine	gemcitabine	Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response	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.

Secondary Outcome Measures

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

Locations (1): 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.
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Trivandrum, India