Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma (GEIS-29)
Primary Purpose
Osteosarcoma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gemcitabine plus rapamycin
Sponsored by
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring Osteosarcoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
6 cycles of gemcitabine plus rapamycin
Outcomes
Primary Outcome Measures
Progression free survival (PFS) rate
Secondary Outcome Measures
Tumor response according to RECIST
Full Information
NCT ID
NCT02429973
First Posted
April 24, 2015
Last Updated
April 28, 2015
Sponsor
Broto, Javier Martín, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT02429973
Brief Title
Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
Acronym
GEIS-29
Official Title
Multicenter and Prospective Phase II Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Broto, Javier Martín, M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteosarcoma
Keywords
Osteosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
6 cycles of gemcitabine plus rapamycin
Intervention Type
Drug
Intervention Name(s)
Gemcitabine plus rapamycin
Intervention Description
Gemcitabine and rapamycin given in combination
Primary Outcome Measure Information:
Title
Progression free survival (PFS) rate
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Tumor response according to RECIST
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Martin, PhD
Organizational Affiliation
Virgen del Rocío Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma
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