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

Gustave Roussy

Status and phase: Unknown; Phase 2

Conditions: Germ Cell Tumor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00127049

GIP-TG

Details and patient eligibility

About

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.

Sex: Male

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)