Combination Chemotherapy and Pegfilgrastim in Treating Patients With Previously Untreated Germ Cell Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00470366
First received: May 3, 2007
Last updated: August 14, 2014
Last verified: August 2014
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Paclitaxel, Ifosfamide, and Cisplatin in Previously Untreated Intermediate and Poor Risk Germ Cell Tumor Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Rate of complete response [ Time Frame: At the completion of therapy ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 55
Study Start Date: March 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: pegfilgrastim Drug: cisplatin Drug: ifosfamide Drug: paclitaxel

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 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.

  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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00470366

Locations
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
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
ClinicalTrials.gov Identifier: NCT00470366     History of Changes
Other Study ID Numbers: 07-044, MSKCC-07044
Study First Received: May 3, 2007
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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 IV ovarian germ cell tumor
stage IV extragonadal seminoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Ovarian Neoplasms
Teratoma
Central Nervous System Neoplasms
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Genital Neoplasms, Male
Genital Diseases, Male
Testicular Diseases
Isophosphamide mustard
Cisplatin
Ifosfamide
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on August 27, 2014