First Line TIP in Poor Prognosis TGCTs.

Study Overview
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Brief Summary
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TIP in the 1st line treatment of GCTs patients with unfavorable decline of serum tumor markers after 1 cycle of the BEP regimen.TIP will be administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Detailed Description
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Cycle 1: BEP regimen Serum tumor markers at day 18-21: •Patients with an unfavorable pattern of tumor marker decrease after 1 cycle of BEP will receive 4 more cycles of TIP. TIP regimen: Taxol 250 mg/ m2 iv on day 1 Ifosfamid 1,2 g/ m2/ day iv x 5 days Cisplatin 20 mg/ m2/ day iv x 5 days One cycle of therapy consists of 22 days. Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Official Title
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A Treatment Strategy of the Use of 1st Line Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors Based on Tumor Marker Decline: A Phase II Trial of Paclitaxel, Ifosfamid and Cisplatin Regimen.

Conditions
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Germ Cell Tumor

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Ifosfamide
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 16 years. Evidence of NSGCT based on histologic examination or based on clinical evidence and high serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are very elevated) Testicular, retroperitoneal, or mediastinal primary site. Evidence of disseminated disease (clinical stages II or III). Disease classified as poor prognosis according to IGCCCG criteria: Primary mediastinal NSGCT or Non-pulmonary visceral metastases or HCG > 50,000 UI/l, or AFP > 10,000 ng/ml, or LDH > 10 times the upper normal value. No prior chemotherapy. No previous carcinoma, except basal-cell carcinoma of the skin. Adequate renal function: measured or calculated creatinine clearance> 60 ml/min. Absolute granulocyte count >= 1,500/mm3, platelets >= 100,000 mm3, bilirubine <= 1.5 fold the upper normal value. Unfavorable tumor marker decline after 1.cycle of BEP Signed informed consent. Exclusion Criteria: Patients infected by the Human Immunodeficiency Virus (HIV). Patients who do not fit inclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous chemotherapy<br>TIP regimen: Paclitaxel 250 mg/ m2 iv on day 1 Ifosfamide 1,2 g/ m2/ day iv x 5 days Cisplatin 20 mg/ m2/ day iv x 5 days | Drug: Paclitaxel<br>* paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements<br>* Other names: paclitaxel ebewe;Drug: Ifosfamide<br>* paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements<br>* Other names: ifosfamide-holoxan;Drug: Cisplatin<br>* paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements<br>* Other names: cisplatin-hospira;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate | according RECIST criteria version 1.1 | 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | response rate after chemotherapy | 36 month | 
| Progression-free survival | expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate | 36 month | 
| Number of adverse events grade III and IV |  | 36 month | 
| overall survival | Survival will be estimated from the registration date to the date of last follow-up or death. Patients will be followed at least 3 years. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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poor-prognosis germ cell cancer, paclitaxel, ifosfamid and cisplatin regimen, tumor marker decline