Gemcitabine, Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Progressive or Relapsed Metastatic Germ Cell Tumors
NCT00551122 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2013-01-23
Summary
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.
Conditions
- Brain and Central Nervous System Tumors
- Extragonadal Germ Cell Tumor
- Ovarian Cancer
- Testicular Germ Cell Tumor
Interventions
- BIOLOGICAL
- BIOLOGICAL
-
lenograstim
- BIOLOGICAL
- DRUG
- DRUG
-
gemcitabine hydrochloride
- DRUG
-
ifosfamide
- DRUG
Sponsors & Collaborators
-
University Hospital Southampton NHS Foundation Trust
collaborator OTHER -
University of Southampton
lead OTHER
Principal Investigators
-
G. Mead, MD · University Hospital Southampton NHS Foundation Trust
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2013-04-30
Countries
- United Kingdom
Study Locations
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