Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00104676
First received: March 3, 2005
Last updated: December 13, 2009
Last verified: November 2008
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.


Condition Intervention Phase
Extragonadal Germ Cell Tumor
Teratoma
Testicular Germ Cell Tumor
Biological: bleomycin sulfate
Drug: cisplatin
Drug: etoposide
Drug: ifosfamide
Drug: oxaliplatin
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival rate after 1 course of treatment [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: November 2003
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).
Biological: bleomycin sulfate
At least one course administered
Drug: cisplatin
At least one course administered
Drug: etoposide
At least one course administered
Experimental: Arm II
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.
Biological: bleomycin sulfate
At least one course administered
Drug: cisplatin
At least one course administered
Drug: etoposide
At least one course administered
Drug: ifosfamide
Given in a dose-dense sequential fashion
Drug: oxaliplatin
Given in a dose-dense sequential fashion
Drug: paclitaxel
Given in a dose-dense sequential fashion

Detailed Description:

OBJECTIVES:

  • Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin, etoposide, and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin, etoposide, and cisplatin OR dose-dense sequential combination chemotherapy.
  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study.

Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP. Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive 3 additional courses of BEP.
  • Arm II: Patients receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.

PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:

    • Histologically confirmed NSGCT
    • Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels
  • Clinical stage II-III disease (disseminated disease)
  • Testicular, retroperitoneal, or mediastinal primary site
  • Poor prognosis disease, meeting 1 of the following criteria:

    • Mediastinal primary site
    • Non-pulmonary visceral metastases
    • One of the following lab values:

      • HCG > 50,000 UI/L
      • AFP > 10,000 ng/mL
      • Lactate dehydrogenase > 10 times upper limit of normal (ULN)

PATIENT CHARACTERISTICS:

Age

  • Over 16

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine clearance > 60 mL/min

Other

  • No other prior malignancy except basal cell skin cancer
  • No HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104676

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U    713-792-3245      
France
Centre Paul Papin Recruiting
Angers, France, 49100
Contact: Remy Delva    33-49-800-918-507      
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Nguyen Binh Bui, MD    33-5-5633-3813      
C.H.U. de Brest Recruiting
Brest, France, 29609
Contact: Jean-Pierre Malhaire, MD    33-298-223-333 ext. 233-95      
Centre Regional Francois Baclesse Recruiting
Caen, France, 14076
Contact: Emmanuel Sevin, MD    33-2-3145-5000    e.sevin@baclesse.fr   
CHU de Grenoble - Hopital de la Tronche Recruiting
Grenoble, France, 38043
Contact: Francois Ringeisen    33-4-7676-5537      
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Armelle Caty, MD    33-32-029-5959    acaty@o-lambret.fr   
Centre Leon Berard Recruiting
Lyon, France, 69008
Contact: Aude Flechon    33-4-78-78-26-45      
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Gwenaelle Gravis, MD    33-4-9122-3740    gravisg@marseille.fnclcc.fr   
Hopital Notre-Dame de Bon Secours Recruiting
Metz, France, 57038
Contact: Christian Platini, MD    33-3-8755-3554    cplatini@chr-metz-thionville.fr   
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Stephane Culine, MD    33-4-6761-3755    stculine@valdorel.fnclcc.fr   
CRLCC Nantes - Atlantique Recruiting
Nantes-Saint Herblain, France, 44805
Contact: Frederic Rolland, MD    33-2-40-67-99-76    F-rolland@nantes.fnclcc.fr   
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Antoine Thyss, MD    33-04-9203-1538    antoine.thyss@cal.nice.fnclcc.fr   
Hopital Tenon Recruiting
Paris, France, 75970
Contact: Jean-Pierre Lotz, MD    33-1-5601-6058    jean-pierre.lotz@tnn.ap-hop-paris.fr   
Hopital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: Stephane Oudard, MD, PhD    33-1-56-093-476    stephane.oudard@hop.egp.ap-hop-paris.fr   
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Jean-Christophe Eymard, MD    33-03-2650-4444    jc.eymard@reims.fnclcc.fr   
Centre Eugene Marquis Recruiting
Rennes, France, 35042
Contact: Pierre Kerbrat, MD, PhD    33-299-253-280    kerbrat@rennes.fnclcc.fr   
Centre Hospitalier de Rodez Recruiting
Rodez, France, 12027
Contact: Laurent Mosser    33-05-6575-1212      
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Paule Chinet-Charrot    33-2-3208-2222      
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Christine Chevreau-Dalbianco, MD    33-56-142-4114    chevreau.christine@claudiusregaud.fr   
Centre Hospitalier Universitaire Bretonneau de Tours Recruiting
Tours, France, 37044
Contact: Claude Linassier, MD, PhD    33-2-4747-3827    linassier@med.univ-tours.fr   
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Lionnel Geoffrois, MD    33-3-8359-8400      
Institut Gustave Roussy Recruiting
Villejuif, France, F-94805
Contact: Karim Fizazi, MD, PhD    33-1-4211-4559    fizazi@igr.fr   
Slovakia
National Cancer Institute - Bratislava Recruiting
Bratislava, Slovakia, 833 10
Contact: Maria Reckova, MD    421-2-5937-8366    maria.reckova@nou.sk   
Sponsors and Collaborators
UNICANCER
Investigators
Investigator: Karim Fizazi, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00104676     History of Changes
Other Study ID Numbers: CDR0000416124, FRE-FNCLCC-GETUG-13/0206, EU-20502
Study First Received: March 3, 2005
Last Updated: December 13, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma and yolk sac tumor
testicular choriocarcinoma
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor
stage II extragonadal non-seminomatous germ cell tumor
stage III extragonadal non-seminomatous germ cell tumor
testicular immature teratoma
testicular mature teratoma
adult teratoma

Additional relevant MeSH terms:
Teratoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Bleomycin
Etoposide phosphate
Isophosphamide mustard
Oxaliplatin
Cisplatin
Etoposide
Ifosfamide
Paclitaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on April 15, 2014