Trial Information

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

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