Pemetrexed in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer

Study Overview
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Brief Summary
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Patients with relapsed or chemotherapy-refractory SCLC have a dismal prognosis. Unfortunately, available treatments result in few durable responses. Pemetrexed is a well-tolerated agent, which is active in NSCLC. Since chemotherapy agents, which are active in NSCLC, are usually also active in SCLC, this trial will examine the efficacy and activity of pemetrexed in this palliative setting

Detailed Description
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OUTLINE: This is a multi-center study. Pemetrexed 500 mg/m2 i.v. q 3 wks All patients will also receive folic acid 350-1000 mcg. po once daily beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, Vitamin B12 1000 mcg. IM every 9 weeks beginning approximately 1 week prior to the first dose of pemetrexed and continuing until completion of pemetrexed, and dexamethasone 4 mg po bid the day before, the day of, and the day following each treatment with pemetrexed Chest x-ray will be performed prior to each cycle (if other disease assessment by imaging is not performed) in order to ensure patients are not rapidly progressing. Cycles are repeated every 3 weeks for up to 6 cycles or PD or intolerable side effects. Performance Status: ECOG 0, 1, or 2 Life Expectancy: Not specified Hematopoietic: WBC > 3000/mm3 ANC > 1500/mm3 Platelet count > 100,000/mm3 Hemoglobin > 8 g/dL Hepatic: Bilirubin < 1.0 X upper limit of normal Aspartate aminotransferase (AST, SGOT) < 2.5 x upper limit of normal. AST may be < 5 x upper limit of normal for patients with liver metastasis Renal: Creatinine clearance of > 45 ml/ min (by Cockcroft-Gault) Cardiovascular: No unstable or uncompensated cardiovascular conditions Pulmonary: No unstable or uncompensated respiratory conditions

Official Title
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Pemetrexed (Alimta) in Patients With Chemosensitive and Chemoresistant Relapsed Small Cell Lung Cancer: A Hoosier Oncology Group Phase II Study (LUN04-78)

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological proof of neuroendocrine cancers (including small cell cancers of any site [including lung] or poorly differentiated neuroendocrine cancers of the lung with (unidimensionally) measurable disease as per the RECIST criteria Chemoresistant or chemosensitive disease Patients must have received treatment with at least one but not more than 2 prior chemotherapy regimens, including one regimen containing a platinum agent Radiation therapy must have completed their radiation at least 14 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to < grade 1 or baseline prior to registration Negative pregnancy test Exclusion Criteria: No clinically significant infections as judged by the treating investigator No symptomatic CNS metastasis No radiation to > 25% of the marrow containing spaces No previous treatment with pemetrexed No uncontrolled pleural effusions No current breastfeeding

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pemetrexed for patients with chemosensitive and chemoresistant relapsed small cell lung cancer. | Drug: Pemetrexed<br>* Pemetrexed 500 mg/m2 IV q 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To estimate the clinical benefit rate (CR, PR, SD) of pemetrexed in two patient populations with small cell lung cancer: chemosensitive and chemoresistant relapsed independently. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the toxicity of pemetrexed; To estimate the time to disease progression; To estimate overall survival |  | 12 months |