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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
Broto, Javier Martín, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteosarcoma focused on measuring Osteosarcoma

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 24, 2015
    Last Updated
    April 28, 2015
    Sponsor
    Broto, Javier Martín, M.D.
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    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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