Chemotherapy for Patients With Osteosarcoma

Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas

The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.

• To assess how well treatment with pemetrexed works for patients with your type of cancer
• To assess for any side effects that might be associated with pemetrexed.
• To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.

Inclusion Criteria:

• Histological diagnosis of high grade locally advanced or metastatic osteosarcoma
• Must have one prior chemotherapy regimen for advanced disease
• At least 1 unidimensional measurable lesion by computed tomography (CT) scan
• Have a good performance status
• Adequate organ function

Exclusion Criteria:

• Have a serious concomitant systemic disorder (for example active Human Immunodeficiency Virus infection)
• Have brain metastases not adequately treated
• Significant weight loss (that is more than 20%) over the previous 6 weeks before study entry
• Inability or unwillingness to take folic acid or vitamin B12 supplementation and corticosteroids
• Pregnant or breast-feeding