NCT00127595

Brief Summary

This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
Last Updated

August 24, 2005

Status Verified

August 1, 2005

First QC Date

August 5, 2005

Last Update Submit

August 23, 2005

Conditions

Carcinoma, Transitional Cell

Keywords

carcinoma of the urothelial tract

Outcome Measures

Primary Outcomes (1)

  • response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)

Secondary Outcomes (3)

  • overall survival

  • disease free survival

  • toxicity

Interventions

gemcitabine, oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Transitional cell carcinoma
  • Histologically-proven
  • Locally advanced unresectable or metastatic
  • With at least one measurable target
  • Informed consent signed

You may not qualify if:

  • Previous chemotherapy
  • Previous radiotherapy
  • Performance status \>=2
  • Peripheral neuropathy \>=1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

gemcitabine-oxaliplatin regimen

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Christine THEODORE, Dr

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2005

First Posted

August 8, 2005

Study Start

January 1, 2002

Study Completion

April 1, 2005

Last Updated

August 24, 2005

Record last verified: 2005-08

Locations

FR(1)