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A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis


Phase 2
16 Years
N/A
Open (Enrolling)
Male
Germ Cell Tumor

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Trial Information

A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis


Inclusion Criteria:



- Patients older than 16 years

- Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based
on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein
(AFP)

- Relapsed disease classified as good prognosis according to the Memorial
Sloan-Kettering Cancer Center (MSKCC) classification criteria:

- Testicular primary site

- Prior treatment limited to one program (or 6 or fewer cycles of cisplatin)

- Either a complete response or a partial response with normal serum AFP and HCG

- Relapse documented by rising AFP and/or HCG or by a biopsy

- 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, bilirubin < 1.5
fold the upper normal value

- Signed informed consent.

Exclusion Criteria:

- Patients infected by the human immunodeficiency virus (HIV)

- Patients who do not fit inclusion criteria

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Principal Investigator

Karim FIZAZI, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GIP-TG

NCT ID:

NCT00127049

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Germ Cell Tumor
  • Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)
  • Neoplasms, Germ Cell and Embryonal

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