Back to resultsTrial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
Primary Purpose
Germ Cell Tumor
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
gemcitabine, ifosfamide, cisplatin, G-CSF
Sponsored by
About this trial
This is an interventional treatment trial for Germ Cell Tumor focused on measuring Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)
Eligibility 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
Sites / Locations
- Institut Gustave RoussyRecruiting
Outcomes
Primary Outcome Measures
Complete response rate
Secondary Outcome Measures
Toxicity
Progression free survival
Overall survival
Full Information
NCT ID
NCT00127049
First Posted
August 3, 2005
Last Updated
September 7, 2006
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00127049
Brief Title
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
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 Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Germ Cell Tumor
Keywords
Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
gemcitabine, ifosfamide, cisplatin, G-CSF
Primary Outcome Measure Information:
Title
Complete response rate
Secondary Outcome Measure Information:
Title
Toxicity
Title
Progression free survival
Title
Overall survival
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim FIZAZI, Dr
Phone
33 1 42114559
Email
fizazi@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, Dr
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim FIZAZI, Dr
Phone
33 1 42114559
Email
fizazi@igr.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
24595454
Citation
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.
Results Reference
derived
Learn more about this trial
Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
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