Phase 2
Completed N=32
Chemotherapy for Patients With Osteosarcoma
Source: ClinicalTrials.gov NCT00523419 ↗Enrolled (actual)
32
Serious AEs
34.4%
Results posted
Sep 2010
Primary outcomePrimary: Percentage of Participants With Tumor Response — 3.1; 0; 3.1; 15.6 percentage of participants
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.
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 | — |
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
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. Informational only — not medical advice.