Chemotherapy for Patients With Osteosarcoma

Lilly

Status and phase

Completed

Phase 2

Conditions

Osteosarcoma

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00523419

11814

H3E-EW-S115 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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