High-dose Chemotherapy With Autologous Stem Cell Transplantation in Poor Prognosis Germ-cell Tumors: TAXIF II

NCT00231582 | Completed Phase 2 DMC

• 1 other identifier: P031101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

High-dose chemotherapy (HD-CT) is able to circumvent platinum-resistance of resistant/refractory germ-cell tumors (GCTs), but expectancy of cure remains low. New strategies are needed with new drugs and a sequential approach. Patients with relapsed (but not absolutely refractory to Cisplatinum-based chemotherapy) poor-prognosis GCTs are scheduled to receive 2 cycles combining epirubicin and paclitaxel followed by 3 consecutive HD-CT supported by stem cell transplantation. One course will combine Taxol, 360 mg/m² + thiotepa, 720 mg/m², followed by two ICE regimens (Ifosfamide, 12 g/m², carboplatin, AUC 20, etoposide, 1500 mg/m²). This phase II study is designed as a Gehan method. The main objective of the study is the complete response rate. With this aim in view, it is planned to enroll in its first step 14 patients to insure that if no complete response (CR) is noticed, study would be stopped for inefficacy (i.e., a CR rate lower than 20%). If one or more CR are noticed, protocol specified that up to 45 patients will be included in order to reduce the confidence interval (CI) of the CR rate. Secondary objectives are the overall response rate (RR), the overall survival (OS) and the progression-free survival (PFS) rates, toxicity and toxic death rate. The statistical analysis is done in terms of intent-to-treat.

Conditions

Testicular Neoplasms

Keywords

High-dose with autologous germ-cell tumors

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response rate

  during de study

Secondary Outcomes (1)

• Survival (overall and progression-free), toxicity, toxic-death rate.

  during the study

Study Arms (1)

1

EXPERIMENTAL

1

Drug: epirubicin; Procedure: high-dose and autologous stem cell transplantation; Drug: paclitaxel; Drug: etoposide; Drug: ifosfamide; Drug: carboplatin

Interventions

epirubicin DRUG

epirubicin

1

high-dose and autologous stem cell transplantation PROCEDURE

high-dose and autologous stem cell transplantation

1

paclitaxel DRUG

paclitaxel

1

etoposide DRUG

etoposide

1

ifosfamide DRUG

ifosfamide

1

carboplatin DRUG

carboplatin

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility requirements includes the following criteria:
• Age \>18 years and \< 65
• Performance status \< 3
• Histologically or biologically documented GCTs
• Testicular, abdominal, or mediastinal tumors
• Measurable or evaluable disease
• Life expectancy \> 3 months
• Normal cardiac, liver, and renal function tests
• Absence of infection
• HIV negative test
• Signed informed consent
• All patients had to have been previously treated with at least one line of a cisplatin-containing regimen and were included if they were refractory after one or two line(s) of cisplatin-based CT, or had relapsed after two lines of a cisplatin-based CT

You may not qualify if:

• Fireproof diseases (progress unless month with regard to the last cycle of chemotherapy or in the course of chemotherapy)
• Relapses after complete answer obtained by surgery ( sCR )
• Neuropathy of superior rank or = II - renal Function (Office) superior creatinine or = 125 mmol/l and/or clearance of the creatinine subordinate or = II 60ml / mn
• Antecedents of congestive even compensated cardiac insufficiency
• Hurts of growing teratoma that is measurable hurts increasing by size (cutting) in the absence of rise of marker pens
• Extensive chemotherapy with support of haematopoietic stem cells. NB: A previous preventive irradiation under diaphragmatitis for a seminoma stage I (dose from 24 to 30 Gy in classic spreading) does not establish one against formal indication. However, an estimation clarifies capacities of the haematopoietic marrow is recommended with observation of the evolution of the NFP in the course of chemotherapy and quantification of cells CD 34 + in the peripheral blood. It's the same of the case where a chemotherapy by carboplatine was realized

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• Amgen: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Hôpital TENON, Service d'Oncologie Médicale

Paris, 75020, France

Location

Related Publications (2)

• Lotz JP, Bui B, Gomez F, Theodore C, Caty A, Fizazi K, Gravis G, Delva R, Peny J, Viens P, Duclos B, De Revel T, Cure H, Gligorov J, Guillemaut S, Segura C, Provent S, Droz JP, Culine S, Biron P; Groupe d'Etudes des Tumeurs Uro-Genitales (GETUG). Sequential high-dose chemotherapy protocol for relapsed poor prognosis germ cell tumors combining two mobilization and cytoreductive treatments followed by three high-dose chemotherapy regimens supported by autologous stem cell transplantation. Results of the phase II multicentric TAXIF trial. Ann Oncol. 2005 Mar;16(3):411-8. doi: 10.1093/annonc/mdi087. Epub 2005 Jan 19.

  PMID: 15659420 BACKGROUND

• Selle F, Wittnebel S, Biron P, Gravis G, Roubaud G, Bui BN, Delva R, Bay JO, Flechon A, Geoffrois L, Caty A, Soares DG, de Revel T, Fizazi K, Gligorov J, Miclea JM, Dubot C, Provent S, Temby I, Gaulet M, Horn E, Brindel I, Lotz JP. A phase II trial of high-dose chemotherapy (HDCT) supported by hematopoietic stem-cell transplantation (HSCT) in germ-cell tumors (GCTs) patients failing cisplatin-based chemotherapy: the Multicentric TAXIF II study. Ann Oncol. 2014 Sep;25(9):1775-1782. doi: 10.1093/annonc/mdu198. Epub 2014 Jun 3.

  PMID: 24894084 DERIVED

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

Epirubicin; Paclitaxel; Etoposide; Ifosfamide; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes

Study Officials

• Jean-Pierre LOTZ, Pr,MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 4, 2005
• Study Start: September 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 25, 2011

Record last verified: 2007-03

Locations

FR (1)