Trial With Gemcitabine and Rapamycin in Second Line of Metastatic Osteosarcoma (GEIS-29)

April 28, 2015 updated by: Broto, Javier Martín, M.D.

Multicenter and Prospective Phase II 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. The study includes 6 cycles of the combination gemcitabine+rapamycin in metastatic or unresectable osteosarcoma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
6 cycles of gemcitabine plus rapamycin
Drug: Gemcitabine plus rapamycin
Gemcitabine and rapamycin given in combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS) rate
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumor response according to RECIST
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Broto, Javier Martín, M.D.

Investigators

  • Principal Investigator: Javier Martin, PhD, Virgen del Rocio Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC11-444 OSTEOSARC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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