Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma

NCT ID: NCT02429973

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-04-30

Brief 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.

Detailed 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.

Conditions

Osteosarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

6 cycles of gemcitabine plus rapamycin

Group Type: EXPERIMENTAL

Gemcitabine plus rapamycin

Intervention Type: DRUG

Gemcitabine and rapamycin given in combination

Interventions

Gemcitabine plus rapamycin

Gemcitabine and rapamycin given in combination

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Broto, Javier Martín, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Martin, PhD

Role: PRINCIPAL_INVESTIGATOR

Virgen del Rocío Hospital

Other Identifiers

EC11-444 OSTEOSARC

Identifier Type: -

Identifier Source: org_study_id