MDACC Study Summary DM02-056

Study Summary
No. DM02-056:.......Genitourinary......Lance Pagliaro......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	DM02-056

Study Title:	A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients with Poor-Prognosis Dissemenated Non-Seminomatous Germ Cell Tumors: A Phase III Trial.

Physician

New Patient Referral



Name:	Lance Pagliaro	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Genitourinary	Supported By:	SANOFI

Phase of Study:	Phase III	Return Visit:	Weekly during active chemotherapy phase. After Chemo: a. once every 2 months for 2 years b. once every 4 months in the 3rd year c. once every 6 months in the 4th year d. once every year after the 4th year.

Treatment Agents:	Bleomycin Cisplatin Etoposide Ifosfamide Oxaliplatin Paclitaxel	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	During BEP and T-BEP-Oxali patients will be admitted for 5 days every 21 days. During the Plat-Ifo-Bleo regimen, patients may be admitted for 1 day every 21 days (can be given as outpatient, will require the patient to stay for 7 to 8 hours).


Description/ Intervention:	The goal of this clinical study is to find out if treating patients who have aggressive non-seminomatous germ cell tumor(s) with a more intensive chemotherapy is better than standard chemotherapy (BEP). This study will also investigate long term survival, change in the disease status, and the side effects of this new dose-dense regimen.

Study Objectives / Outcomes

Primary: To compare the progression-free survival of patients with poor prognosis NSGCT and slow decrease in the serum level of tumor markers after 1 cycle of the BEP regimen, treated randomly either by 3 subsequent cycles of BEP (BEP arm) or by a dose-dense regimen called T-BEP-Oxali/Plat-Ifo-Bleo (Dose-dense arm).

Secondary:
1. To evaluate the response rate, progression-free survival and toxicity in both treatment groups (control and study group) with slow decrease in the serum tumor markers.
2. To evaluate the response rate, progression-free survival, overall survival and toxicity in patients with a fast decrease in the serum levels of tumor markers

Study Status Information



Study Activation / Registration Date:	05/11/2004

IRB Review and Approval Date:	08/07/2002

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	260

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients older than 16 years.

2) Evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum HCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are elevated)

3) Testicular, retroperitoneal, or mediastinal primary site.

4) Evidence of disseminated disease (clinical stages II or III).

5) Disease classified as poor prognosis according to IGCCCG criteria: a) Primary mediastinal NSGCT (any stage) or b) Non-pulmonary visceral metastases or c) HCG > 50,000 UI/l, or AFP > 10,000 ng/ml, or LDH > 10 times the upper normal value.

6) No prior chemotherapy.

7) No previous malignancy, except for basal-cell carcinoma of the skin.

8) Adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance> 60 ml/min

9) Cockcroft formula: CLcr = [(140-age) x weight(Kg)]/[72 x creat (mg/dl)] (for females, multiply by 0.85)

10) Absolute granulocyte count >/= 1,500/mm^3, platelets >/= 100,000 mm^3, bilirubine >/= 1.5x the upper limit of normal value.

11) Signed informed consent.

Exclusion Criteria:

1) Patients infected by the Human Immunodeficiency Virus (HIV).

2) Patients who do not fit inclusion

3) Female patients.

4) There will be no exclusion criteria based on performance status, life expectancy, site of metastases, lung function, or ureteral compression.

5) Female gender is excluded because: 1) this disease is extremely rare in females; 2) it's biology is different; 3) pre-treatment prognostic classification to good or poor-prognosis categories has not been developed; and 4) the clinical behavior of the disease in women is different.

6) The effects of the combination chemotherapy regimens used in this trial on children and HIV infected patients are unknown. The evaluation of toxicity of this trial can be confounded by antiretroviral therapy; therefore, patients younger than 16 and HIV positive patients will not be included in this trial.

Links

Registration Number: NCT00104676
Study Information on Clinical Trials Registry (clinicaltrials.gov)