Advanced/Metastatic Osteosarcoma MedDRA version: 9.1 Level: PT Classification code 10031294 Term: Osteosarcoma metastatic
Conditions
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Histological diagnosis of high grade locally advanced or metastatic osteosarcoma (WHO classification), not amenable to surgery, radiation, or combined modality therapy with curative intent. [2] One prior chemotherapy regimen for advanced disease; neo-adjuvant is not counted towards this requirement. Pemetrexed is considered as second line chemotherapy for advanced/metastatic disease. [3] At least one unidimensionally measurable lesion meeting RECIST criteria (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques). Positron emission tomography [PET] scans and ultrasounds may not be used. At least one measurable lesion outside of the field of any prior radiation therapy (according to RECIST criteria). Prior radiotherapy to a single index lesion is not allowed. Osseous lesions with soft tissue tumor at study entry (excluding completely calcified or necrosed lesion) are considered measurable lesions. [4] Have a performance status of 0, 1, or 2 on the ECOG scale [5] Adequate organ function including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.0 x 10e9/L, platelets =100 x 10e9/L (in case of bone marrow disease: =75 x 10e9/L), and hemoglobin =9.0g/dL. Hepatic: bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [13] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [14] Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [15] Inability to comply with protocol or study procedures. [16] Have a serious concomitant systemic disorder (e.g. active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s safety or the patient’s ability to adhere to the protocol. [17] Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. [18] Have a concurrent serious infection. [19] Have a psychiatric disorder that prevents patients from providing informed consent or following protocol instructions. No other severe medical illness, including psychosis and previous history of severe cardiovascular disease. [20] Have a prior malignancy other than osteosarcoma, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score 1.3 g/day or other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam). [26] Inability or unwillingness to take folic acid or vitamin B12 supplementation. [27] Inability to take corticosteroids. [28] Pregnant or breast-feeding. [29] Have had a recent (within 30 days of study treatment) or concurrent yellow fever vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the antitumor activity of pemetrexed therapy, as measured by tumor response rate according to RECIST, in patients with advanced/metastatic osteosarcomas. ;Secondary Objective: * To assess the following efficacy variables: - duration of response for responding patients - progression-free survival - time to treatment failure - overall survival time * To examine the toxicity (NCI-CTC, version 3.0) and safety profile of study treatment * Correlation of disease outcome with pharmacogenomic analysis; MTAP gene deletion, FRa and FPGS expression will be correlated with the clinical data to determine the association between these factors and clinical outcome to treatment. ;Primary end point(s): The primary outcome measure is the tumor response rate. | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed