Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors - Full Text View

Sponsor:	UNICANCER
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00104676

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:

MedlinePlus related topics: Cancer

Drug Information available for: Ifosfamide Bleomycin Cisplatin Paclitaxel Etoposide Oxaliplatin Etoposide phosphate

U.S. FDA Resources

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

Institut Gustave Roussy

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 May 21, 2012