Chemotherapy for Patients With Osteosarcoma

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Pemetrexed

Criteria

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