Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas - N/A

• Conditions: Advanced/Metastatic Osteosarcoma; MedDRA version: 9.1Level: PTClassification code 10031294Term: Osteosarcoma metastatic

• Registration Number: EUCTR2007-000912-97-DE
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

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 < or = 1.5 times the upper limit of normal (x ULN), alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = 3.0 x ULN (AP, AST, and ALT < or = 5 x ULN is acceptable if the liver has tumor involvement).
Renal: calculated creatinine clearance (CrCl) =45 mL/min based on the standard Cockcroft and Gault formula.
[6] Estimated life expectancy of at least 12 weeks.
[7] Patient compliance and geographic proximity that allow adequate follow-up.
[8] Prior radiation therapy allowed to <25% of the bone marrow. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
[9] Patients must sign an informed consent document.
[10] Patients must be at least 18 years of age.
[11] Fully recovered from any previous surgery and prior chemotherapy (at least 4 weeks since major surgery or prior myelosuppressive chemotherapy). With the exception of alopecia, patients must have resolution of all acute toxic effects of any prior surgery or chemotherapy to NCI-CTC (Version 3.0) grade = 1.
[12] For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment and must not be breast-feeding.
For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after the treatment period.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 < or = 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
[21] Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). A screening computerized tomography (CT) or magnetic resonance imaging (MRI) before enrollment in the absence of a clinical suspicion of brain metastases is not required.
[22] Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that can not be controlled by drainage or other procedures prior to study entry.
[23] Significant weight loss (that is =20%) over the previous 6 weeks before study entry.
[24] Concurrent administration of any other antitumor therapy.
[25] Inability to discontinue administration of aspirin at a dose >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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified