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

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Brief Title

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

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

Brief 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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete response rate

Secondary Outcome

 Toxicity

Condition

Germ Cell Tumor

Intervention

gemcitabine, ifosfamide, cisplatin, G-CSF


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

37

Start Date

December 2004



Eligibility Criteria

        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
      

Gender

Male

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karim FIZAZI, Dr, 33 1 42114559, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00127049

Organization ID

GIP-TG



Study Sponsor

Gustave Roussy, Cancer Campus, Grand Paris


Study Sponsor

Karim FIZAZI, Dr, Principal Investigator, Gustave Roussy, Cancer Campus, Grand Paris


Verification Date

September 2006