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

No results posted yet for this study

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

Interventions

BIOLOGICAL

filgrastim

BIOLOGICAL

lenograstim

BIOLOGICAL

pegfilgrastim

DRUG

cisplatin

DRUG

gemcitabine hydrochloride

DRUG

ifosfamide

DRUG

paclitaxel

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00551122 on ClinicalTrials.gov