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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00002596
Other study ID # SWOG-9442
Secondary ID MSKCC-94076CLB-9
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated June 25, 2013
Start date September 1994
Est. completion date July 2006

Study information

Verified date October 2003
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.


Description:

OBJECTIVES:

- Compare the efficacy of bleomycin, etoposide, and cisplatin (BEP) with or without high-dose carboplatin, etoposide, and cyclophosphamide plus autologous bone marrow or peripheral blood stem cell transplantation in male patients with poor- or intermediate-risk germ cell tumors.

- Compare the toxicity of these regimens in these patients.

- Compare prospectively the prognosis in terms of the rate of decline of the serum tumor markers, human chorionic gonadotropin (hCG) and alpha-fetoprotein (AFP), in patients treated with these regimens.

- Correlate hCG and AFP with complete response and survival in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and risk status (poor vs intermediate). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive bleomycin IV on days 1, 8, and 15 and etoposide (VP-16) IV over 30-60 minutes and cisplatin (CDDP) IV over 30-60 minutes on days 1-5 (BEP). Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-16 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. G-CSF is discontinued 24 hours before initiating subsequent courses of chemotherapy, and withheld on days of bleomycin administration.

- Arm II: Patients receive 2 courses of BEP and G-CSF as in arm I. Patients who have no marrow involvement with tumor undergo harvest of autologous bone marrow before the first or second course of BEP. Patients who have bone marrow involvement with tumor undergo harvest of G-CSF-mobilized autologous peripheral blood stem cells (PBSC) on days 17-21 of the first and/or second courses of BEP. When blood counts recover, patients receive high-dose intensification comprising carboplatin IV over 1 hour, VP-16 IV over 30-60 minutes, and cyclophosphamide IV over 1 hour on days -5 to -3. Autologous bone marrow or PBSC are reinfused over 15-20 minutes on day 0. G-CSF is administered SC beginning 24 hours after transplantation and continuing until blood counts recover. Beginning 1-3 weeks after hospital discharge for the first transplantation and after recovery from any toxic effects, patients with a Karnofsky performance status of 70-100% receive a second course of high-dose intensification plus a second bone marrow or PBSC transplantation in the absence of disease progression or unacceptable toxicity.

Patients on both arms with brain metastases at presentation undergo radiotherapy and/or surgery concurrently with BEP, if medically indicated.

Patients with normal alpha fetoprotein (AFP) and human chorionic gonadotropin (hCG) tumor marker levels after completion of treatment on arm I or II undergo surgical resection of all residual masses. Patients who have no residual malignant tumor or undergo complete resection of only a mature teratoma receive no further therapy. Patients on arm I who undergo complete resection of residual malignant tumor receive 2 additional courses of VP-16 and CDDP without bleomycin. Patients on arm II who undergo complete resection of residual malignant tumor receive no additional chemotherapy. Patients with an unresectable residual malignant tumor receive additional therapy at the discretion of the treating physician. Patients with residual tumor marker (AFP and hCG) positivity after treatment on arm I or II undergo resection of residual masses if tumor marker values fall to normal by marker half-life.

PROJECTED ACCRUAL: A total of 270 patients (135 per treatment arm) will be accrued for this study within 4.4 years.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically proven poor-risk, nonseminoma germ cell tumor

- Must meet 1 of the following 3 conditions:

- Testis or retroperitoneal primary site without visceral metastasis but with any of the following tumor marker values:

- Lactic dehydrogenase (LDH) greater than 10 times upper limit of normal (ULN)

- Human chorionic gonadotropin (hCG) greater than 50,000 IU/L

- Alpha-fetoprotein (AFP) greater than 10,000 ng/mL

- Testis or retroperitoneal primary site with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values), including the following:

- Bone

- Brain

- Liver

- Other nonpulmonary viscera (e.g., skin, spleen)

- Mediastinal primary site, regardless of presence/absence of visceral metastasis or tumor marker values OR

- Histologically proven intermediate-risk, nonseminoma germ cell tumor

- Testis or retroperitoneal primary site with no visceral metastasis (except lung), and with any of the following tumor marker values:

- LDH 3-10 times ULN

- hCG 5,000-50,000 IU/L

- AFP 1,000-10,000 ng/mL OR

- Histologically proven intermediate-risk, seminoma germ cell tumor with 1 or more nonpulmonary visceral metastases (regardless of tumor marker values or primary site), including the following:

- Bone

- Brain

- Liver

- Other nonpulmonary visceral metastasis (e.g., skin, spleen)

- Histologic confirmation may be delayed, at the discretion of the protocol chairman, until after initiation of study therapy for patients with a testicular mass and elevated AFP or hCG if medical circumstances warrant immediate treatment

- Measurable or evaluable disease

- Concurrent registration on protocol MSKCC-89076 (SWOG-9345) for tumor biology studies required

PATIENT CHARACTERISTICS:

Age:

- 12 and over

Sex:

- Male

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- See Disease Characteristics

Renal:

- Creatinine no greater than ULN* OR

- Creatinine clearance greater than 50 mL/min* NOTE: * Abnormal levels due to ureteral obstruction by tumor allowed at the discretion of the protocol chairman

Other:

- HIV negative

- No other concurrent malignancy except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 30 days since prior radiotherapy except for brain metastases or documented disease progression

- Recovered from the toxic effects of any prior radiotherapy

Surgery:

- Recovered from the effects of any recent surgery

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
bleomycin sulfate

filgrastim

Drug:
carboplatin

cisplatin

cyclophosphamide

etoposide

Procedure:
autologous bone marrow transplantation

bone marrow ablation with stem cell support

conventional surgery

peripheral blood stem cell transplantation

Radiation:
radiation therapy


Locations

Country Name City State
Australia Westmead Hospital Westmead New South Wales
Peru Instituto de Enfermedades Neoplasicas Lima
Puerto Rico San Juan City Hospital San Juan
Puerto Rico University of Puerto Rico School of Medicine Medical Sciences Campus San Juan
United States MBCCOP - University of New Mexico HSC Albuquerque New Mexico
United States Harrington Cancer Center Amarillo Texas
United States Veterans Affairs Medical Center - Amarillo Amarillo Texas
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Northeast Alabama Regional Medical Center Anniston Alabama
United States Veterans Affairs Medical Center - Asheville Asheville North Carolina
United States Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Veterans Affairs Medical Center - Baltimore Baltimore Maryland
United States Green Mountain Oncology Group Bennington Vermont
United States Mountain States Tumor Institute Boise Idaho
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Tuft-New England Medical Center Boston Massachusetts
United States Albert Einstein Clinical Cancer Center Bronx New York
United States Roswell Park Cancer Institute Buffalo New York
United States Veterans Affairs Medical Center - Buffalo Buffalo New York
United States Fletcher Allen Health Care - University Health Center Campus Burlington Vermont
United States Vermont Cancer Center Burlington Vermont
United States Cooper University Hospital Camden New Jersey
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States Martha Jefferson Hospital Charlottesville Virginia
United States Louis A. Weiss Memorial Hospital Chicago Illinois
United States Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois
United States University of Chicago Cancer Research Center Chicago Illinois
United States Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago Illinois
United States Veterans Affairs Medical Center - Lakeside Chicago Chicago Illinois
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States Ireland Cancer Center Cleveland Ohio
United States Ellis Fischel Cancer Center - Columbia Columbia Missouri
United States Veterans Affairs Medical Center - Columbia (Truman Memorial) Columbia Missouri
United States Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio
United States NorthEast Oncology Associates Concord North Carolina
United States Veterans Affairs Medical Center - Dallas Dallas Texas
United States CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania
United States CCOP - Dayton Dayton Ohio
United States University of Colorado Cancer Center Denver Colorado
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center Des Moines Iowa
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States City of Hope Comprehensive Cancer Center Duarte California
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Veterans Affairs Medical Center - Durham Durham North Carolina
United States Elmhurst Hospital Center Elmhurst New York
United States Veterans Affairs Medical Center - Fargo Fargo North Dakota
United States Cape Fear Valley Health System Fayetteville North Carolina
United States Broward General Medical Center Fort Lauderdale Florida
United States Brooke Army Medical Center Fort Sam Houston Texas
United States Fort Wayne Medical Oncology and Hematology, Incorporated Fort Wayne Indiana
United States CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin
United States Sutter Health Western Division Cancer Research Group Greenbrae California
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Hackensack University Medical Center Hackensack New Jersey
United States Milton S. Hershey Medical Center Hershey Pennsylvania
United States Memorial Regional Hospital Comprehensive Cancer Center Hollywood Florida
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States MBCCOP - Hawaii Honolulu Hawaii
United States St. Mary's Medical Center Huntington West Virginia
United States Indiana University Cancer Center Indianapolis Indiana
United States Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana
United States Holden Comprehensive Cancer Center Iowa City Iowa
United States University of Mississippi Medical Center Jackson Mississippi
United States Queens Cancer Center of Queens Hospital Jamaica New York
United States University of Kansas Medical Center Kansas City Kansas
United States Lenoir Memorial Hospital Cancer Center Kinston North Carolina
United States Rebecca and John Moores UCSD Cancer Center La Jolla California
United States CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Veterans Affairs Medical Center - Las Vegas Las Vegas Nevada
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Jonsson Comprehensive Cancer Center, UCLA Los Angeles California
United States USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California
United States Baptist Hospital East - Louisville Louisville Kentucky
United States Texas Tech University Health Science Center Lubbock Texas
United States University of Wisconsin Comprehensive Cancer Center Madison Wisconsin
United States Veterans Affairs Medical Center - Madison Madison Wisconsin
United States CCOP - North Shore University Hospital Manhasset New York
United States North Shore University Hospital Manhasset New York
United States CCOP - Marshfield Medical Research and Education Foundation Marshfield Wisconsin
United States Loyola University Medical Center Maywood Illinois
United States Danville Radiation Therapy Center Memphis Tennessee
United States University of Tennessee Cancer Institute Memphis Tennessee
United States CCOP - Mount Sinai Medical Center Miami Beach Florida
United States University of Minnesota Cancer Center Minneapolis Minnesota
United States Veterans Affairs Medical Center - Minneapolis Minneapolis Minnesota
United States Morristown Memorial Hospital Morristown New Jersey
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Memorial Sloan-Kettering Cancer Center New York New York
United States Mount Sinai Medical Center, NY New York New York
United States Weill Medical College of Cornell University New York New York
United States CCOP - Christiana Care Health Services Newark Delaware
United States Virginia Oncology Associates - Norfolk Norfolk Virginia
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Chao Family Comprehensive Cancer Center Orange California
United States St. Joseph Hospital - Orange Orange California
United States Florida Hospital Cancer Institute Orlando Florida
United States Alegent Health-Midlands Community Hospital Papillion Nebraska
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania
United States FirstHealth Moore Regional Hospital Pinehurst North Carolina
United States University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania
United States CCOP - Columbia River Oncology Program Portland Oregon
United States Oregon Cancer Institute Portland Oregon
United States Lifespan: The Miriam Hospital Providence Rhode Island
United States Ministry Medical Group - Northern Region Rhinelander Wisconsin
United States MBCCOP - Massey Cancer Center Richmond Virginia
United States West Suburban Center for Cancer Care River Forest Illinois
United States Oncology and Hematology Associates of Southwest Virginia, Inc. Roanoke Virginia
United States James P. Wilmot Cancer Center Rochester New York
United States Saint Anthony Medical Center Rockford Illinois
United States Sutter Cancer Center Sacramento California
United States University of California Davis Cancer Center Sacramento California
United States Lakeland Medical Center - St. Joseph Saint Joseph Michigan
United States Barnes-Jewish Hospital Saint Louis Missouri
United States St. Louis University Health Sciences Center Saint Louis Missouri
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Huntsman Cancer Institute Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Veterans Affairs Medical Center - San Diego San Diego California
United States UCSF Comprehensive Cancer Center San Francisco California
United States Veterans Affairs Medical Center - San Francisco San Francisco California
United States CCOP - Virginia Mason Research Center Seattle Washington
United States Puget Sound Oncology Consortium Seattle Washington
United States Louisiana State University Health Sciences Center - Shreveport Shreveport Louisiana
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States Stanford University Medical Center Stanford California
United States CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Veterans Affairs Medical Center - Syracuse Syracuse New York
United States CCOP - Northwest Tacoma Washington
United States Arizona Cancer Center Tucson Arizona
United States CCOP - Oklahoma Tulsa Oklahoma
United States John Muir Medical Center Walnut Creek California
United States Lombardi Cancer Center Washington District of Columbia
United States Veterans Affairs Medical Center - Washington, DC Washington District of Columbia
United States Walter Reed Army Medical Center Washington District of Columbia
United States Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center West Palm Beach Florida
United States Veterans Affairs Medical Center - White River Junction White River Junction Vermont
United States CCOP - Wichita Wichita Kansas
United States New Hanover Regional Medical Center Wilmington North Carolina
United States CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts

Sponsors (5)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Cancer and Leukemia Group B, Eastern Cooperative Oncology Group, National Cancer Institute (NCI), Southwest Oncology Group

Countries where clinical trial is conducted

United States,  Australia,  Peru,  Puerto Rico, 

References & Publications (2)

Bajorin DF, Nichols CR, Margolin KA, et al.: Phase III trial of conventional-dose chemotherapy alone or with high-dose chemotherapy for metastatic germ cell tumors (GCT) patients (PTS): a cooperative group trial by Memorial Sloan-Kettering Cancer Center,

Motzer RJ, Nichols CJ, Margolin KA, Bacik J, Richardson PG, Vogelzang NJ, Bajorin DF, Lara PN Jr, Einhorn L, Mazumdar M, Bosl GJ. Phase III randomized trial of conventional-dose chemotherapy with or without high-dose chemotherapy and autologous hematopoie — View Citation

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