Phase II Trial for the Treatment of Relapsed Osteosarcoma

• Status: Terminated
• Trial end date: 2019-01-07
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italian Sarcoma Group
• Treatments: Docetaxel; Gemcitabine; Ifosfamide; Isophosphamide mustard

Criteria

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