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Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00470366
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Ovarian Cancer
Teratoma
Testicular Germ Cell Tumor
Biological: pegfilgrastim
Drug: cisplatin
Drug: ifosfamide
Drug: paclitaxel
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Cisplatin Paclitaxel Pegfilgrastim Ifosfamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of complete response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Number of courses required to achieve maximal response [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: March 2007
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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 cisplatin IV over 30 minutes, ifosfamide IV over 60 minutes, and paclitaxel IV over 60 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.

After completion of study treatment, patients are followed at 28 days and then every 2 months for up to 1 year.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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 or 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 or 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 < 2 times ULN
  • Bilirubin < 1.5 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00470366

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Darren Feldman, MD     646-422-4491        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Darren Feldman, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Robert J. Motzer, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Darren Feldman )
Study ID Numbers: CDR0000543824, MSKCC-07044
Study First Received: May 3, 2007
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00470366  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II 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
stage I malignant testicular germ cell tumor
adult central nervous system germ cell tumor
ovarian choriocarcinoma
ovarian dysgerminoma
ovarian embryonal carcinoma
ovarian yolk sac tumor
ovarian immature teratoma
ovarian mature teratoma
ovarian monodermal and highly specialized teratoma
ovarian polyembryoma
ovarian mixed germ cell tumor
stage I ovarian germ cell tumor
stage II ovarian germ cell tumor

Study placed in the following topic categories:
Gonadal Disorders
Seminoma
Urogenital Neoplasms
Nonseminomatous germ cell tumor
Ovarian Diseases
Central Nervous System Neoplasms
Genital Diseases, Female
Cisplatin
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Endocrine Gland Neoplasms
Extragonadal Germ Cell Tumor
Ovarian cancer
Ovarian Neoplasms
Choriocarcinoma
Genital Neoplasms, Female
Endocrine System Diseases
Testicular Neoplasms
Carcinoma
Ifosfamide
Dysgerminoma
Paclitaxel
Mechlorethamine
Testicular cancer
Endocrinopathy
Teratoma
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Nervous System Diseases
Physiological Effects of Drugs
Antimitotic Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on February 12, 2009