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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Extragonadal Germ Cell Tumor, Testicular Germ Cell Tumor

Thank you

Trial Information

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


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.

PROJECTED ACCRUAL: A total of 470 patients (235 per treatment arm) will be accrued for this
study within 5.5 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Robert J. Motzer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000339340

NCT ID:

NCT00072215

Start Date:

April 2004

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Martha Jefferson HospitalCharlottesville, Virginia  22901
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Baptist Hospital East - LouisvilleLouisville, Kentucky  40207
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Broward General Medical CenterFort Lauderdale, Florida  33316
Florida Hospital Cancer InstituteOrlando, Florida  32804
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Northeast Alabama Regional Medical CenterAnniston, Alabama  36207
Veterans Affairs Medical Center - San DiegoSan Diego, California  92161
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Veterans Affairs Medical Center - Washington, DCWashington, District of Columbia  20422
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Fort Wayne Medical Oncology and Hematology, IncorporatedFort Wayne, Indiana  46885-5099
Veterans Affairs Medical Center - Las VegasLas Vegas, Nevada  89106
Queens Cancer Center of Queens HospitalJamaica, New York  11432
Veterans Affairs Medical Center - AshevilleAsheville, North Carolina  28805
Veterans Affairs Medical Center - DallasDallas, Texas  75216
Virginia Oncology Associates - NorfolkNorfolk, Virginia  23502
St. Mary's Medical CenterHuntington, West Virginia  25701
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
NorthEast Oncology Associates - ConcordConcord, North Carolina  28025
Oncology and Hematology Associates of Southwest Virginia, Incorporated - RoanokeRoanoke, Virginia  24014
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Cape Fear Valley Medical CenterFayetteville, North Carolina  28302-2000
Comprehensive Cancer Center at Moore Regional HospitalPinehurst, North Carolina  28374
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
Miriam Hospital at LifespanProvidence, Rhode Island  02906
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Western Pennsylvania Cancer Institute at Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224-1791
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Palm Beach Cancer Institute - West Palm BeachWest Palm Beach, Florida  33401