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


Phase 3
16 Years
N/A
Open (Enrolling)
Both
Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival rate after 1 course of treatment

Safety Issue:

No

Principal Investigator

Karim Fizazi, MD, PhD

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

Unspecified

Study ID:

CDR0000416124

NCT ID:

NCT00104676

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Teratoma
  • Testicular Germ Cell Tumor
  • 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
  • Teratoma
  • Neoplasms, Germ Cell and Embryonal

Name

Location

M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009