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Sponsored by: |
Southampton General Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00551122 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, ifosfamide, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with paclitaxel, ifosfamide, and cisplatin, and to see how well they work in treating patients with progressive or relapsed metastatic germ cell tumors.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Extragonadal Germ Cell Tumor Ovarian Cancer Testicular Germ Cell Tumor |
Drug: cisplatin Drug: filgrastim Drug: gemcitabine hydrochloride Drug: ifosfamide Drug: lenograstim Drug: paclitaxel Drug: pegfilgrastim |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Multicentre Trial of Salvage Chemotherapy With Gem-TIP for Relapsed Germ Cell Cancer |
Estimated Enrollment: | 23 |
Study Start Date: | November 2006 |
OBJECTIVES:
OUTLINE: This is a multicenter, phase I dose-escalation study of gemcitabine hydrochloride followed by a phase II study.
After completion of study therapy, patients are followed periodically for up to 1 year and then at the investigator's discretion.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets the following criteria:
Histologically confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
In first relapse after a single prior cisplatin-containing combination chemotherapy
No patients with cerebral metastases alone
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United Kingdom, England | |
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | Recruiting |
Birmingham, England, United Kingdom, B15 2TH | |
Contact: Michael H. Cullen, MD 0121-627-2444 | |
Royal Marsden - Surrey | Recruiting |
Sutton, England, United Kingdom, SM2 5PT | |
Contact: Robert A. Huddart, MD 44-20-8661-3457 robert.huddart@icr.ac.uk | |
Southampton General Hospital | Recruiting |
Southampton, England, United Kingdom, SO16 6YD | |
Contact: G. Mead, MD 44-23-8079-8639 |
Study Chair: | G. Mead, MD | Southampton General Hospital |
Study ID Numbers: | CDR0000572096, USCTU-UR1002-GEM-TIP, EU-20769, EUDRACT-2004-004804-19 |
Study First Received: | October 25, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00551122 |
Health Authority: | Unspecified |
recurrent malignant testicular germ cell tumor testicular seminoma recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor stage III malignant testicular germ cell tumor testicular choriocarcinoma and seminoma testicular embryonal carcinoma and seminoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and yolk sac tumor with seminoma |
testicular yolk sac tumor and teratoma with seminoma recurrent extragonadal non-seminomatous germ cell tumor recurrent extragonadal seminoma stage IV extragonadal non-seminomatous germ cell tumor stage IV extragonadal seminoma recurrent extragonadal germ cell tumor ovarian mixed germ cell tumor adult central nervous system 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 Gemcitabine Nervous System Neoplasms Endocrine Gland Neoplasms Extragonadal Germ Cell Tumor Ovarian cancer Ovarian Neoplasms |
Lenograstim Choriocarcinoma Genital Neoplasms, Female Endocrine System Diseases Testicular Neoplasms Malignant germ cell tumor Recurrence Carcinoma Ifosfamide Paclitaxel Mechlorethamine Testicular cancer Endocrinopathy Teratoma Isophosphamide mustard |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Nervous System Diseases Mitosis Modulators |
Adjuvants, Immunologic Enzyme Inhibitors Antimitotic Agents Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic |