NCT02429973

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

April 24, 2015

Last Update Submit

April 28, 2015

Conditions

Osteosarcoma

Keywords

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS) rate

    4 months

Secondary Outcomes (1)

  • Tumor response according to RECIST

    6 months

Study Arms (1)

Experimental

EXPERIMENTAL

6 cycles of gemcitabine plus rapamycin

Drug: Gemcitabine plus rapamycin

Interventions

Gemcitabine plus rapamycinDRUG

Gemcitabine and rapamycin given in combination

Experimental

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteosarcoma

Interventions

GemcitabineSirolimus

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingMacrolidesLactonesOrganic Chemicals

Study Officials

  • Javier Martin, PhD

    Virgen del Rocío Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2015

First Posted

April 29, 2015

Study Start

July 1, 2012

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

April 29, 2015

Record last verified: 2015-04