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
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: August 3, 2005
Last updated: September 7, 2006
Last verified: September 2006
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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00127049

Contact: Karim FIZAZI, Dr 33 1 42114559

Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Karim FIZAZI, Dr    33 1 42114559   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Karim FIZAZI, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): 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
Testicular Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Gonadal Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Testicular Diseases
Urogenital Neoplasms
Isophosphamide mustard
Alkylating Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016