Brief Title
Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis
Official Title
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.
Brief Summary
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Complete response rate(by chemotherapy or chemotherapy + surgery), pathological complete response rate.
Secondary Outcome
Progression free survival
Condition
Germ Cell Tumors
Intervention
Paclitaxel
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
101
Start Date
March 13, 2009
Completion Date
October 5, 2020
Primary Completion Date
October 5, 2020
Eligibility Criteria
Inclusion Criteria:
1. Germ cell tumors whatever histology (TGNS or séminoma : TGS ) whose origin is gonadic,
extra-gonadic, retro-peritoneal or primitive mediastinal
2. Age >= 18 years old
3. Histologically confirmed germ cell tumor (TGS) or biomarkers rate allowing to diagnose
germ cell tumor without histology (TGNS)
4. 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.
5. TGNS or TGS in relapse after 2 treatment lines
6. 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
7. ECOG Performance status 0-2
8. 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
9. Cardiac Functions (FEV >= 50%), Respiratory Functions , neurological Functions
compatibles with high dose chemotherapy administration
10. Absence of previous intensification
11. Patient Information and Informed consent signature
12. HIV and B and C hepatitis negative serologies
13. Negative pregnancy test for women with reproductive potential and adequate
contraception before study entry
14. Patient affiliated to social security system
Exclusion Criteria:
1. Patients whose diagnosis of relapse was not confirmed by an anatomopathological
examination or by an increase of tumors markers
2. Primitive encephalic germ cell tumors
3. 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
4. Growing Teratoma lesions
5. Patients with HIV infection, hepatitis B and C
6. Patients with symptomatic brain metastases despite appropriate corticosteroid
treatment
7. Associated pathology may prevent the patient to receive treatment, creatinine
clearance ≤ 50 mL / min (calculated by Cockcroft-Gault)
8. FEV <50%
9. History of cancer (except basal cell epithelioma skin cancer) in the 3 years preceding
the entry into the trial
10. Patient already included in another clinical trial involving an experimental molecule
11. Pregnant or breast feeding women
12. Persons without liberty or under guardianship,
13. Geographical, social or psychological conditions that do not permit compliance with
protocol
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christine CHEVREAU, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00864318
Organization ID
08 GENH 06
Responsible Party
Sponsor
Study Sponsor
Institut Claudius Regaud
Study Sponsor
Christine CHEVREAU, MD, Principal Investigator, Institut Claudius Regaud
Verification Date
January 2021