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NCT00127595 Clinical Trial

Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract

Carcinoma, Transitional Cell Clinical Trial

Official title:
A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00127595
Other study ID # GEMOX
Secondary ID
Status Terminated
Phase Phase 2
First received August 5, 2005
Last updated August 23, 2005
Start date January 2002
Est. completion date April 2005

Study information
Verified date August 2005
Source Gustave Roussy, Cancer Campus, Grand Paris
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 28
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Transitional cell carcinoma

- Histologically-proven

- Locally advanced unresectable or metastatic

- With at least one measurable target

- Informed consent signed

Exclusion Criteria:

- Previous chemotherapy

- Previous radiotherapy

- Performance status >=2

- Peripheral neuropathy >=1

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gemcitabine, oxaliplatin

Locations
Country Name City State
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
Secondary overall survival
Secondary disease free survival
Secondary toxicity
See also
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Recruiting NCT05874921 - uTRACT Jelmyto Registry: A Registry of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
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Completed NCT00722553 - Study of Pralatrexate to Treat Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder Phase 2
Recruiting NCT00146276 - Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer Phase 3
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Recruiting NCT01189838 - The Expression and Effect of Cyr61 in Urinary Tract Transitional Cell Carcinoma N/A
Withdrawn NCT00172367 - Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma Phase 2
Completed NCT00191971 - 2nd Line Gemcitabine Monotherapy for Transitional Cell Carcinoma of Urothelium (TCC) After CDDP Regimen Phase 2
Terminated NCT04039867 - Evaluation of Oxaliplatin and Gemcitabine in Patients With Metastatic Bladder Cancer Phase 2
Completed NCT01529411 - Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer Phase 2