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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: August 5, 2005
Last Update Posted: September 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
August 3, 2005
August 5, 2005
September 8, 2006
December 2004
Not Provided
Complete response rate
Same as current
Complete list of historical versions of study NCT00127049 on ClinicalTrials.gov Archive Site
  • Toxicity
  • Progression free survival
  • Overall survival
  • Toxicity
  • Progression
  • Free survival
  • Overall survival
Not Provided
Not Provided
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
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
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Germ Cell Tumor
Drug: gemcitabine, ifosfamide, cisplatin, G-CSF
Not Provided
Fizazi K, Gravis G, Flechon A, Geoffrois L, Chevreau C, Laguerre B, Delva R, Eymard JC, Rolland F, Houede N, Laplanche A, Burcoveanu D, Culine S. Combining gemcitabine, cisplatin, and ifosfamide (GIP) is active in patients with relapsed metastatic germ-cell tumors (GCT): a prospective multicenter GETUG phase II trial. Ann Oncol. 2014 May;25(5):987-91. doi: 10.1093/annonc/mdu099. Epub 2014 Mar 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
Not Provided
Not Provided

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
Sexes Eligible for Study: Male
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Gustave Roussy, Cancer Campus, Grand Paris
Not Provided
Principal Investigator: Karim FIZAZI, Dr Gustave Roussy, Cancer Campus, Grand Paris
Gustave Roussy, Cancer Campus, Grand Paris
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP