Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
NCT ID: NCT00470366
Last Updated: 2017-11-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-03-31
2016-06-30
Brief Summary
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PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors.
Detailed Description
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* Determine the efficacy of chemotherapy comprising paclitaxel, ifosfamide, and cisplatin in combination with pegfilgrastim in patients with previously untreated intermediate- or poor-risk germ cell tumors.
* Determine the safety of this regimen in these patients.
* Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression, these patients may receive 1-2 more courses of chemotherapy after surgery.
After completion of study treatment, patients are followed up at 28 days and then every 2 months for up to 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Paclitaxel, Ifosfamide, and Cisplatin
-Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles.
pegfilgrastim
cisplatin
ifosfamide
paclitaxel
Interventions
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pegfilgrastim
cisplatin
ifosfamide
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed germ cell tumor meeting 1 of the following criteria:
* Poor risk, defined by any of the following:
* Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following:
* Pretreatment serum lactate dehydrogenase (LDH) \> 10 times upper limit of normal (ULN)
* Pretreatment serum human chorionic gonadotropin (HCG) \> 50,000 IU/L
* Pretreatment serum alpha fetoprotein (AFP) \> 10,000 ng/mL
* Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values):
* Bone metastases
* Brain metastases
* Hepatic metastases
* Any nonpulmonary metastases (i.e., skin, spleen)
* Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases
* Modified intermediate risk, defined by any of the following:
* Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values:
* Pretreatment serum LDH 3.0-10 times ULN
* Pretreatment serum HCG 5,000-50,000 IU/L
* Pretreatment serum AFP 1,000-10,000 ng/mL
* Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):
* Bone metastases
* Brain metastases
* Hepatic metastases
* Any nonpulmonary visceral metastases (i.e., skin, spleen)
* Previously untreated disease
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine normal or creatinine clearance \> 50 mL/min (unless renal dysfunction is due to tumor obstructing the ureters)
* AST and ALT ≤ 3 times ULN
* Bilirubin ≤ 2.0 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent malignancy except for nonmelanoma skin cancer
* No known HIV positivity
* No active infections
PRIOR CONCURRENT THERAPY:
* Recovered from prior surgery
* More than 30 days since prior radiotherapy and recovered (unless evidence of progressive disease has been documented)
* No prior chemotherapy
* No other concurrent cytotoxic therapy
* Concurrent radiotherapy and surgery allowed for treatment of brain metastases
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Darren Feldman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Robert J. Motzer, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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MSKCC-07044
Identifier Type: -
Identifier Source: secondary_id
07-044
Identifier Type: -
Identifier Source: org_study_id