Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors
Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor
About this trial
This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring recurrent malignant testicular germ cell tumor, stage III malignant testicular germ cell tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular choriocarcinoma, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular seminoma, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, testicular yolk sac tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, testicular immature teratoma, testicular mature teratoma, recurrent extragonadal germ cell tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites: Seminoma Testis Retroperitoneum Mediastinum Other extragonadal site Nonseminoma Testis Retroperitoneum Other extragonadal site No tumor of the mediastinum Must have evidence of metastatic disease, including either of the following: Unidimensionally measurable lesions At least 20 mm by conventional techniques (e.g., physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR at least 10 mm by spiral CT scan or MRI Nonmeasurable lesions, including the following: Small lesions Bone lesions Pleural or pericardial effusions Ascites Irradiated lesions, unless progression is documented after radiotherapy Progressive or recurrent disease meeting at least 1 of the following criteria: Measurable progressive disease Biopsy-proven residual disease Persistently elevated or rising ß-human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) titers with no other clear cause for elevation Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with or without bleomycin AND exhibits clinical resistance by at least 1 of the following conditions after therapy*: Progressive GCT after a partial response to first-line therapy Relapse after complete response (CR) to first-line therapy, including partial response (PR) surgically converted to CR Second testicular primary with evidence of metastases after first-line therapy Relapse after adjuvant chemotherapy NOTE: *Patients failing to achieve PR or CR with first-line therapy as evidenced by rising markers or new disease within 4 weeks of first-line therapy are not eligible PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic Bilirubin ≤ 1.5 times upper limit of normal* (ULN) AST and ALT ≤ 2.5 times ULN* NOTE: *Unless hepatic metastases are present Renal Creatinine ≤ 1.5 times ULN OR Creatinine clearance ≥ 50 mL/min Other Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No prior dose-intensive therapy with stem cell replacement Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy No prior paclitaxel No prior docetaxel No prior ifosfamide No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy Concurrent or sequential radiotherapy to brain metastases allowed No other concurrent palliative radiotherapy Surgery See Disease Characteristics Concurrent surgery for brain metastases allowed Other Recovered from prior therapy
Sites / Locations
- Northeast Alabama Regional Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- Naval Medical Center - San Diego
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center at Georgetown University Medical Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Cancer Institute at Memorial Regional Hospital
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute
- Palm Beach Cancer Institute - West Palm Beach
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- CCOP - Evanston
- CCOP - Illinois Oncology Research Association
- West Suburban Center for Cancer Care
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Holden Comprehensive Cancer Center at University of Iowa
- Baptist Hospital East - Louisville
- Greenebaum Cancer Center at University of Maryland Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- UMASS Memorial Cancer Center - University Campus
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- CCOP - Kansas City
- Siteman Cancer Center at Barnes-Jewish Hospital
- Missouri Baptist Cancer Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- New Hampshire Oncology-Hematology, PA - Hooksett
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Cancer Institute of New Jersey at the Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- New York Weill Cornell Cancer Center at Cornell University
- Mount Sinai Medical Center
- SUNY Upstate Medical University Hospital
- Veterans Affairs Medical Center - Syracuse
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- NorthEast Oncology Associates - Concord
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Medical Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Moore Regional Hospital
- Zimmer Cancer Center at New Hanover Regional Medical Center
- Comprehensive Cancer Center at Wake Forest University
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
- Oklahoma University Medical Center
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- Miriam Hospital at Lifespan
- Veterans Affairs Medical Center - Dallas
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Vermont Cancer Center at University of Vermont
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
- St. Mary's Medical Center
- Ministry Medical Group at Saint Mary's Hospital
- McGill Cancer Centre at McGill University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Regimen A: TIP
Regimen B: VeIP