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

Phase 2
18 Years
Not Enrolling

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Trial Information

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

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

- Pregnant or breast-feeding

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Tumor Response

Outcome Description:

Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis * 100.

Outcome Time Frame:

Baseline to 21 months

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

September 2007

Completion Date:

June 2010

Related Keywords:

  • Osteosarcoma
  • Osteosarcoma