Phase II Trial for the Treatment of Relapsed Osteosarcoma

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

Detailed Description
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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

Official Title
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Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma

Conditions
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OSTEOSARCOMA

Intervention / Treatment
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* Drug: Gemcitabine and Docetaxel
* Drug: Ifosfamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine and Docetaxel<br>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 | Drug: Gemcitabine and Docetaxel<br>* Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle<br>|
| Experimental: Ifosfamide<br>Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks | Drug: Ifosfamide<br>* Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle<br>* Other names: High doses ifosfamide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Survival without progression of disease assessed at 6 months from randomization | at 6 months from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Rate of tumor response assessed after cycle 2, 4 and 6 | After 6, 12 and 18 weeks | 
| Overall Survival | From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months | At patient death or at last available follow-up | 
| Post treatment Surgery Rate | Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles | After 6, 12 and 18 weeks | 
| Adverse Events Incidence | Number and grade of adverse events related to the study treatments | Every 3 weeks up to 22 weeks | 
| Quality of life assesment: data will be collected by using specific oncologic Quality of Life instruments | Quality of Life evaluation related to received chemotherapy | After 6, 12 and 18 weeks and at 12 Months after end of treatment | 
| Duration of hospitalization | Number of days spent in hospital related to treatment received | After 1,3, 4, 6, 7, 9, 10, 12, 13, 15, 16 and 18 weeks |