Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104676

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
France
Centre Paul Papin
Angers, France, 49100
Institut Bergonie
Bordeaux, France, 33076
C.H.U. de Brest
Brest, France, 29609
Centre Regional Francois Baclesse
Caen, France, 14076
CHU de Grenoble - Hopital de la Tronche
Grenoble, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Centre Leon Berard
Lyon, France, 69008
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CRLCC Nantes - Atlantique
Nantes-Saint Herblain, France, 44805
Centre Antoine Lacassagne
Nice, France, 06189
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Tenon
Paris, France, 75970
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35042
Centre Hospitalier de Rodez
Rodez, France, 12027
Centre Henri Becquerel
Rouen, France, 76038
Institut Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, F-94805
Slovakia
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Sponsors and Collaborators
UNICANCER
Investigators
OverallOfficial: Karim Fizazi, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Neoplasms
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Teratoma
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Paclitaxel
Etoposide
Oxaliplatin
Etoposide phosphate
Isophosphamide mustard
Cisplatin
Ifosfamide
Bleomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on December 09, 2016