Phase 2 N=32 Treatment

Chemotherapy for Patients With Osteosarcoma

Osteosarcoma

Bottom Line

View on ClinicalTrials.gov: NCT00523419 ↗

Enrolled (actual)

Serious AEs

34.4%

Results posted

Sep 2010

Primary outcome: Primary: Percentage of Participants With Tumor Response — 3.1; 0; 3.1; 15.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pemetrexed (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jun 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Tumor Response	3.1; 0; 3.1; 15.6; 68.8; 12.5	—
SECONDARY Time to Treatment Failure	—	—
SECONDARY Correlation of Disease Outcome With Pharmacogenomic Analysis	—	—
SECONDARY Number of Participants With Adverse Events (Pharmacology Toxicity)	11; 26	—
SECONDARY Duration of Response	9.5	—
SECONDARY Progression-Free Survival (PFS)	1.4	—
SECONDARY Overall Survival (OS) Time	5.5	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00523419). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.