Clinical trial · Interventional
Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
NCT02429973CI-TRIAL-00017695GEIS-29completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter and prospective phase II trial with gemcitabine and rapamycin in second line of metastatic osteosarcoma. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine plus rapamycin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 6 cycles of gemcitabine plus rapamycin
- interventionNames
- Drug: Gemcitabine plus rapamycin
Primary outcomes (1)
- measure
- Progression free survival (PFS) rate
- timeFrame
- 4 months
Secondary outcomes (1)
- measure
- Tumor response according to RECIST
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent signed before any trial test * Age equal or less than 80 years * Histological diagnosis of high-grade, metastatic or unresectable osteosarcoma in progression * Previous treatment with drugs used in first line: methotrexate, adriamycin, platinum * Measurable disease, acoording to RECIST criteria * ECOG 0-2 Exclusion Criteria: * Patients who have been irradiated on target lesions * ECOG \>2 * Bilirubin levels over normal values. Creatinine over 1.6 mg/dL * History of other cancers except basal cell cancer or cervical cancer adequately treated * Serious cardiovascular disease
References
Publications (0)
Data not yet available
No reference posted for this study.