Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
NCT ID: NCT00127049
Last Updated: 2006-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
37 participants
INTERVENTIONAL
2004-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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gemcitabine, ifosfamide, cisplatin, G-CSF
Eligibility Criteria
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Inclusion Criteria
* 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
16 Years
MALE
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Principal Investigators
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Karim FIZAZI, Dr
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Karim FIZAZI, Dr
Role: primary
References
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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.
Other Identifiers
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GIP-TG
Identifier Type: -
Identifier Source: org_study_id