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

This study is currently recruiting participants.

Verified by Institut Gustave Roussy, September 2006

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00127049

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 II

MedlinePlus related topics: Cancer

Drug Information available for: Ifosfamide Cisplatin Gemcitabine hydrochloride Gemcitabine Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

Further study details as provided by Institut Gustave Roussy:

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

Institut Gustave Roussy

Investigators

Principal Investigator:

Karim FIZAZI, Dr

Institut Gustave Roussy

More Information

Study ID Numbers:	GIP-TG
Study First Received:	August 3, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00127049
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:

Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)

Study placed in the following topic categories:

Ifosfamide
Cisplatin
Mechlorethamine
Neoplasms, Germ Cell and Embryonal

Nonseminomatous germ cell tumor
Gemcitabine
Isophosphamide mustard

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009