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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Extragonadal Germ Cell Tumor; Teratoma; Testicular Germ Cell Tumor

Intervention: bleomycin sulfate (Biological); cisplatin (Drug); etoposide (Drug); ifosfamide (Drug); oxaliplatin (Drug); paclitaxel (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: UNICANCER

Official(s) and/or principal investigator(s):
Karim Fizazi, MD, PhD, Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Summary

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.

Clinical Details

Official title: A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Progression-free survival rate after 1 course of treatment

Overall survival

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

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Centre Paul Papin, Angers 49100, France; Recruiting
Remy Delva, Phone: 33-49-800-918-507

Institut Bergonie, Bordeaux 33076, France; Recruiting
Nguyen Binh Bui, MD, Phone: 33-5-5633-3813

C.H.U. de Brest, Brest 29609, France; Recruiting
Jean-Pierre Malhaire, MD, Phone: 33-298-223-333 ext. 233-95

Centre Regional Francois Baclesse, Caen 14076, France; Recruiting
Emmanuel Sevin, MD, Phone: 33-2-3145-5000, Email: e.sevin@baclesse.fr

CHU de Grenoble - Hopital de la Tronche, Grenoble 38043, France; Recruiting
Francois Ringeisen, Phone: 33-4-7676-5537

Centre Oscar Lambret, Lille 59020, France; Recruiting
Armelle Caty, MD, Phone: 33-32-029-5959, Email: acaty@o-lambret.fr

Centre Leon Berard, Lyon 69008, France; Recruiting
Aude Flechon, Phone: 33-4-78-78-26-45

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille 13273, France; Recruiting
Gwenaelle Gravis, MD, Phone: 33-4-9122-3740, Email: gravisg@marseille.fnclcc.fr

Hopital Notre-Dame de Bon Secours, Metz 57038, France; Recruiting
Christian Platini, MD, Phone: 33-3-8755-3554, Email: cplatini@chr-metz-thionville.fr

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier 34298, France; Recruiting
Stephane Culine, MD, Phone: 33-4-6761-3755, Email: stculine@valdorel.fnclcc.fr

CRLCC Nantes - Atlantique, Nantes-Saint Herblain 44805, France; Recruiting
Frederic Rolland, MD, Phone: 33-2-40-67-99-76, Email: F-rolland@nantes.fnclcc.fr

Centre Antoine Lacassagne, Nice 06189, France; Recruiting
Antoine Thyss, MD, Phone: 33-04-9203-1538, Email: antoine.thyss@cal.nice.fnclcc.fr

Hopital Europeen Georges Pompidou, Paris 75015, France; Recruiting
Stephane Oudard, MD, PhD, Phone: 33-1-56-093-476, Email: stephane.oudard@hop.egp.ap-hop-paris.fr

Hopital Tenon, Paris 75970, France; Recruiting
Jean-Pierre Lotz, MD, Phone: 33-1-5601-6058, Email: jean-pierre.lotz@tnn.ap-hop-paris.fr

Institut Jean Godinot, Reims 51056, France; Recruiting
Jean-Christophe Eymard, MD, Phone: 33-03-2650-4444, Email: jc.eymard@reims.fnclcc.fr

Centre Eugene Marquis, Rennes 35042, France; Recruiting
Pierre Kerbrat, MD, PhD, Phone: 33-299-253-280, Email: kerbrat@rennes.fnclcc.fr

Centre Hospitalier de Rodez, Rodez 12027, France; Recruiting
Laurent Mosser, Phone: 33-05-6575-1212

Centre Henri Becquerel, Rouen 76038, France; Recruiting
Paule Chinet-Charrot, Phone: 33-2-3208-2222

Institut Claudius Regaud, Toulouse 31052, France; Recruiting
Christine Chevreau-Dalbianco, MD, Phone: 33-56-142-4114, Email: chevreau.christine@claudiusregaud.fr

Centre Hospitalier Universitaire Bretonneau de Tours, Tours 37044, France; Recruiting
Claude Linassier, MD, PhD, Phone: 33-2-4747-3827, Email: linassier@med.univ-tours.fr

Centre Alexis Vautrin, Vandoeuvre-les-Nancy 54511, France; Recruiting
Lionnel Geoffrois, MD, Phone: 33-3-8359-8400

Institut Gustave Roussy, Villejuif F-94805, France; Recruiting
Karim Fizazi, MD, PhD, Phone: 33-1-4211-4559, Email: fizazi@igr.fr

National Cancer Institute - Bratislava, Bratislava 833 10, Slovakia; Recruiting
Maria Reckova, MD, Phone: 421-2-5937-8366, Email: maria.reckova@nou.sk

M. D. Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States; Recruiting
Clinical Trials Office - M. D. Anderson Cancer Center at the U, Phone: 713-792-3245

Additional Information

Starting date: November 2003
Last updated: December 13, 2009

Page last updated: August 20, 2015

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