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Phase II Trial for the Treatment of Relapsed Osteosarcoma (OsteoREC2015)

I

Italian Sarcoma Group

Status and phase

Terminated
Phase 2

Conditions

OSTEOSARCOMA

Treatments

Drug: Ifosfamide
Drug: Gemcitabine and Docetaxel

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02718482
OsteoREC2015

Details and patient eligibility

About

Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma

Full description

Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks

Enrollment

7 patients

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of high grade osteosarcoma recurrence
  • Resectable or unresectable recurrence disease within 24 months from the initial diagnosis
  • Pleuro-pulmonary recurrence with more than 2 nodules within 24 months from the initial diagnosis
  • Unresectable first relapse within 24 months from the initial diagnosis
  • Resectable or unresectable second of further recurrence of high grade osteosarcoma
  • Age at diagnosis at least 4years.
  • Karnofsky performance status over 60%.
  • Renal function and hepatic In normal limits for age.
  • L eft ejection ventricular fraction over 50%.
  • White blood cells over 3000 million/liter and platelets 100000 million/liter
  • Birth potential female must agreed to contraception
  • Signed written informed consent

Exclusion criteria

  • Contraindication to the use of any study drugs
  • Mental, social and geographic conditions which fail to ensure adequate adherence to the study
  • Hepatitis and human immunodeficiency virus active infection
  • Pregnancy or breast-feeding
  • Previous treatment with Gemcitabine, Docetaxel and Ifosfamide

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

7 participants in 2 patient groups

Gemcitabine and Docetaxel
Experimental group
Description:
Gemcitabine i.v. 900 mg/m2 in 30 min on day 1 and day 8 every 3 weeks Docetaxel i.v. 75 mg/m2 in 60 min on day 8 every 3 weeks
Treatment:
Drug: Gemcitabine and Docetaxel
Ifosfamide
Experimental group
Description:
Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks
Treatment:
Drug: Ifosfamide

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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