Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors

Germ Cell Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00127049
• Other study ID #: GIP-TG
• Status: Recruiting
• Phase: Phase 2
• First received: August 3, 2005
• Last updated: September 7, 2006
• Start date: December 2004

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Karim FIZAZI, Dr
• Phone: 33 1 42114559
• Email: fizazi[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

This is 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 16 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal

Intervention

Drug:
• gemcitabine, ifosfamide, cisplatin, G-CSF

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate
Secondary	Toxicity
Secondary	Progression free survival
Secondary	Overall survival