Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00072215
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Locations: 79
• Arms: 2
• Duration (Months): 12
• Patients Per Site: 0
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors.

PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.

Condition or Disease	Intervention/Treatment	Phase
Extragonadal Germ Cell Tumor; Testicular Germ Cell Tumor	Drug: cisplatin; Drug: ifosfamide; Drug: paclitaxel; Drug: vinblastine	Phase 3

Detailed Description

OBJECTIVES:

Primary

• Compare the overall survival of men with progressive or recurrent metastatic germ cell tumors treated with paclitaxel, ifosfamide, and cisplatin vs vinblastine, ifosfamide, and cisplatin as second-line therapy.

Secondary

• Compare the progression-free survival of patients treated with these regimens.

• Compare the toxicity profiles of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior complete response or partial response with negative markers for at least 6 months (yes vs no) and relapse at least 2 years after completing first-line chemotherapy for germ cell tumors (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive paclitaxel IV over 24 hours on day 1 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 2-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 7-18 OR pegfilgrastim SC once within 24-72 hours after completion of chemotherapy.

• Arm II: Patients receive vinblastine IV on days 1 and 2 and cisplatin IV over 20-30 minutes and ifosfamide IV over 30 minutes on days 1-5. Patients also receive G-CSF SC on days 7-18 OR pegfilgrastim as in arm I.

In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Study of Paclitaxel, Ifosfamide and Cisplatin Versus Vinblastine, Ifosfamide and Cisplatin as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell Tumors
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen A: TIP	Drug: cisplatin; given IV; Drug: ifosfamide; given IV; Drug: paclitaxel; given IV
Experimental: Regimen B: VeIP	Drug: cisplatin; given IV; Drug: ifosfamide; given IV; Drug: vinblastine; given IV

Outcome Measures

Primary Outcome Measures

1. Overall survival [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northeast Alabama Regional Medical Center	Anniston	Alabama	United States	36207
2	Rebecca and John Moores UCSD Cancer Center	La Jolla	California	United States	92093-0658
3	Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
4	Naval Medical Center - San Diego	San Diego	California	United States	92134-3202
5	Veterans Affairs Medical Center - San Diego	San Diego	California	United States	92161
6	UCSF Comprehensive Cancer Center	San Francisco	California	United States	94115
7	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
8	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
9	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia	United States	20007
10	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5001
11	Veterans Affairs Medical Center - Washington, DC	Washington	District of Columbia	United States	20422
12	Broward General Medical Center	Fort Lauderdale	Florida	United States	33316
13	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida	United States	33021
14	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
15	Florida Hospital Cancer Institute	Orlando	Florida	United States	32804
16	Palm Beach Cancer Institute - West Palm Beach	West Palm Beach	Florida	United States	33401
17	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612
18	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
19	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
20	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
21	CCOP - Evanston	Evanston	Illinois	United States	60201
22	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615-7828
23	West Suburban Center for Cancer Care	River Forest	Illinois	United States	60305
24	Fort Wayne Medical Oncology and Hematology, Incorporated	Fort Wayne	Indiana	United States	46885-5099
25	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
26	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1009
27	Baptist Hospital East - Louisville	Louisville	Kentucky	United States	40207
28	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland	United States	21201
29	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
30	UMASS Memorial Cancer Center - University Campus	Worcester	Massachusetts	United States	01655
31	Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph	Saint Joseph	Michigan	United States	49085
32	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
33	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
34	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
35	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri	United States	65203
36	CCOP - Kansas City	Kansas City	Missouri	United States	64131
37	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
38	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
39	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
40	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
41	Veterans Affairs Medical Center - Las Vegas	Las Vegas	Nevada	United States	89106
42	New Hampshire Oncology-Hematology, PA - Hooksett	Hooksett	New Hampshire	United States	03106
43	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
44	Cancer Institute of New Jersey at the Cooper University Hospital	Camden	New Jersey	United States	08103
45	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
46	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
47	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	East Syracuse	New York	United States	13057
48	Queens Cancer Center of Queens Hospital	Jamaica	New York	United States	11432
49	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
50	North Shore University Hospital	Manhasset	New York	United States	11030
51	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
52	New York Weill Cornell Cancer Center at Cornell University	New York	New York	United States	10021
53	Mount Sinai Medical Center	New York	New York	United States	10029
54	SUNY Upstate Medical University Hospital	Syracuse	New York	United States	13210
55	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
56	Veterans Affairs Medical Center - Asheville	Asheville	North Carolina	United States	28805-9913
57	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	United States	27599-7295
58	NorthEast Oncology Associates - Concord	Concord	North Carolina	United States	28025
59	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
60	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
61	Cape Fear Valley Medical Center	Fayetteville	North Carolina	United States	28302-2000
62	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina	United States	27534-9479
63	Comprehensive Cancer Center at Moore Regional Hospital	Pinehurst	North Carolina	United States	28374
64	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina	United States	28402-9025
65	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
66	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio	United States	43210-1240
67	Oklahoma University Medical Center	Oklahoma City	Oklahoma	United States	73104
68	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States	15224
69	Miriam Hospital at Lifespan	Providence	Rhode Island	United States	02906
70	Veterans Affairs Medical Center - Dallas	Dallas	Texas	United States	75219
71	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390-8852
72	Vermont Cancer Center at University of Vermont	Burlington	Vermont	United States	05401-3498
73	Martha Jefferson Hospital	Charlottesville	Virginia	United States	22902
74	Virginia Oncology Associates - Norfolk	Norfolk	Virginia	United States	23502
75	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037
76	Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke	Roanoke	Virginia	United States	24014
77	St. Mary's Medical Center	Huntington	West Virginia	United States	25701
78	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
79	McGill Cancer Centre at McGill University	Montreal	Quebec	Canada	H2W 1S6

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Robert J. Motzer, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00072215
• Other Study ID Numbers: CALGB-90106; U10CA031946; CDR0000339340
• First Posted: Nov 6, 2003
• Last Update Posted: Jul 4, 2016
• Last Verified: Jul 1, 2016

• Keywords provided by Alliance for Clinical Trials in Oncology: 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
• Additional relevant MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Testicular Neoplasms; Paclitaxel; Vinblastine; Ifosfamide

Study Results

No Results Posted as of Jul 4, 2016