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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00127049
First received: August 3, 2005
Last updated: September 7, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Germ Cell Tumor
Drug: gemcitabine, ifosfamide, cisplatin, G-CSF
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Complete response rate

Secondary Outcome Measures:
  • Toxicity
  • Progression free survival
  • Overall survival

Estimated Enrollment: 37
Study Start Date: December 2004
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127049

Contacts
Contact: Karim FIZAZI, Dr 33 1 42114559 fizazi@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Karim FIZAZI, Dr    33 1 42114559    fizazi@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Karim FIZAZI, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00127049     History of Changes
Other Study ID Numbers: GIP-TG
Study First Received: August 3, 2005
Last Updated: September 7, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Isophosphamide mustard
Gemcitabine
Cisplatin
Ifosfamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 16, 2014