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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470366 |
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 |
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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 |
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 |
Estimated Enrollment: | 41 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
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):
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:
Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Darren Feldman, MD 646-422-4491 |
Principal Investigator: | Darren Feldman, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Robert J. Motzer, MD | Memorial Sloan-Kettering Cancer Center |
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 |
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 |
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 |
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 |