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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Drug: pemetrexed
* Drug: gemcitabine
* Drug: carboplatin
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response | 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 | 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 |  | baseline to measured progressive disease (up to 17.5 months) | 
| Duration of Response |  | time of response to progressive disease (up to 17.5 months) | 
| Time to Treatment Failure |  | baseline to stopping treatment (up to 17.5 months) |