NCT00216216

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed	Pemetrexed 500 mg/m2 IV q 3 weeks

Timeline

• Start date: 2005-01-01
• Primary completion: 2005-10-01
• Completion: 2005-10-01
• First posted: 2005-09-22
• Last updated: 2011-05-02

Locations

16 sites across 1 country: United States