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

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ClinicalTrials.gov Identifier: NCT00127049

Recruitment Status : Unknown

Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was: Recruiting

First Posted : August 5, 2005

Last Update Posted : September 8, 2006

Sponsor:

Information provided by:

Gustave Roussy, Cancer Campus, Grand Paris

Study Description

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.

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	37 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide Cisplatin Gemcitabine Gemcitabine hydrochloride

Genetic and Rare Diseases Information Center resources: Nonseminomatous Germ Cell Tumor

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Complete response rate

Secondary Outcome Measures :

Toxicity
Progression free survival
Overall survival

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years and older (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127049

Contacts

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

Locations

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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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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ClinicalTrials.gov Identifier:	NCT00127049
Other Study ID Numbers:	GIP-TG
First Posted:	August 5, 2005 Key Record Dates
Last Update Posted:	September 8, 2006
Last Verified:	September 2006

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:


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

Additional relevant MeSH terms:

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Neoplasms, Germ Cell and Embryonal Testicular Neoplasms Neoplasms Neoplasms by Histologic Type Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Male Urogenital Neoplasms Endocrine System Diseases Testicular Diseases Gonadal Disorders Gemcitabine Ifosfamide	Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents

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