- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864318
Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis (TICE)
Dose Intensification Phase II Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis. TICE Protocol : Paclitaxel and Ifosfamide Followed by Carboplatine and Etoposide Intensification With Individual Carboplatine Dose Adjustment.
Not randomized, multicentric, national phase II trial estimating the efficacy of an intensification protocol in patients with refractory germ cell tumors with relapse and bad prognosis.
Treatment consists in two Paclitaxel and Ifosfamide intensification cycles followed by three Carboplatine and Etoposide high dose cycles. The point is the individual Carboplatine adjustment to take into account inter-individual patients variability.
This adaptation allow to control each patient plasmatic exposition to avoid both inacceptable toxicities (such as ear toxicity) and a low exposition losing then the benefit of this high dose protocol.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Angers, France, 49933
- Centre Paul Papin
-
Bordeaux, France, 33076
- Institut Bergonié
-
Bordeaux, France, 33075
- Hopital St André
-
Clermont Ferrand, France, 63003
- CHU
-
Lyon, France, 69373
- Centre Leon Berard
-
Marseille, France, 13273
- Institut Paoli Calmette
-
Montpellier, France, 34298
- Institut Val d'aurelle
-
Nice, France, 06050
- Centre Antoine Lacassagne
-
Paris, France, 75970
- Hopital Tenon
-
Strasbourg, France, 67091
- CHU
-
Toulouse, France, 31052
- Institut Claudius Regaud
-
Villejuif, France, 94805
- Institut Gustave Roussy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Germ cell tumors whatever histology (TGNS or séminoma : TGS ) whose origin is gonadic, extra-gonadic, retro-peritoneal or primitive mediastinal
- Age >= 18 years old
- Histologically confirmed germ cell tumor (TGS) or biomarkers rate allowing to diagnose germ cell tumor without histology (TGNS)
Relapse or progression with bad prognosis in 1st treatment line : One of these criteria valid point 4 :
progression after incomplete clinical response (Stable disease) to a Cisplatin basis chemotherapy; biomarker progression 4 weeks following the last chemotherapy cycle administration; progression during the first treatment line without obtention of at least stable disease; primitive mediastinal origin in first relapse.
- TGNS or TGS in relapse after 2 treatment lines
Disease progression ( previous points 4 or 5) documented by :
tumors biomarkers increase (AFP and/or HCG) if no, a biopsy is needed to confirm presence of tumors active cells
- ECOG Performance status 0-2
Biological Function :
Neutrophils >= 1500/mm3, Platelets >= 150.000/mm3 ; normal creatinine (or clearance >= 50 ml/mn) ; SGOT, SGPT <= 2,5N (or 5N if hepatic metastases), Bilirubin < 1,5N
- Cardiac Functions (FEV >= 50%), Respiratory Functions , neurological Functions compatibles with high dose chemotherapy administration
- Absence of previous intensification
- Patient Information and Informed consent signature
- HIV and B and C hepatitis negative serologies
- Negative pregnancy test for women with reproductive potential and adequate contraception before study entry
- Patient affiliated to social security system
Exclusion Criteria:
- Patients whose diagnosis of relapse was not confirmed by an anatomopathological examination or by an increase of tumors markers
- Primitive encephalic germ cell tumors
- Germ cell tumors in relapse with favorable factors of treatment response to conventional chemotherapy (RC sustainable after Cisplatin): prior cRC or incomplete clinical response but with normalization of markers and testicular origin
- Growing Teratoma lesions
- Patients with HIV infection, hepatitis B and C
- Patients with symptomatic brain metastases despite appropriate corticosteroid treatment
- Associated pathology may prevent the patient to receive treatment, creatinine clearance ≤ 50 mL / min (calculated by Cockcroft-Gault)
- FEV <50%
- History of cancer (except basal cell epithelioma skin cancer) in the 3 years preceding the entry into the trial
- Patient already included in another clinical trial involving an experimental molecule
- Pregnant or breast feeding women
- Persons without liberty or under guardianship,
- Geographical, social or psychological conditions that do not permit compliance with protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity
Time Frame: 6 months
|
6 months
|
Progression free survival
Time Frame: 8 years
|
8 years
|
Time to progression
Time Frame: 8 years
|
8 years
|
To find a predictive value for Cystatin C as a biomarker of renal function to avoid next to follow plasmatic concentrations to adapt Carboplatine dose in TICE protocol.
Time Frame: 4 years
|
4 years
|
Etoposide pharmacokinetics (in particular inter-individual variability of Etoposide plasmatic concentrations AUC in such patients
Time Frame: 4 years
|
4 years
|
Genetic polymorphisms involved in response and safety treatments
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christine CHEVREAU, MD, Institut Claudius Regaud
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Neoplasms, Germ Cell and Embryonal
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Carboplatin
- Etoposide
- Paclitaxel
- Ifosfamide
Other Study ID Numbers
- 08 GENH 06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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