Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Osteosarcoma Clinical Trial

— GEIS-29  

Official title:

Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429973
• Other study ID #: EC11-444 OSTEOSARC
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2015
• Last updated: April 28, 2015
• Start date: July 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Broto, Javier Martín, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The trial seeks to analyze progression free survival (PFS), measured as PFS rate at 4 months, in patients with metastatic osteosarcoma who have previously received the most active drugs in this disease (methotrexate, cisplatin, adriamycin and ifosfamide). The treatment schedule consists of a maximum of 6 cycles of 3 weeks of gemcitabine+rapamycin. Gemcitabine is given at 800 mg/m2 in days 1 and 8 in cycles of 21 days. Rapamycin is given at 5 mg per day during treatment duration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteosarcoma

Intervention

Drug:
• Gemcitabine plus rapamycin
Gemcitabine and rapamycin given in combination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Broto, Javier Martín, M.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS) rate		4 months	No
Secondary	Tumor response according to RECIST		6 months	No