Oxaliplatin and Taxotere in Bladder Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Bladder Cancer

Intervention / Treatment

Detailed Description

To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.

Study Type

Interventional

Enrollment (Actual)

10

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Stanford, California, United States, 94305
    - Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patient Population Type: Advanced Muscle Invasive Bladder Cancer
Prior Therapy: One prior therapy for advanced disease
Disease: Measurable disease
ECOG Performance: 0,1
Indication: Histologically Proven Carcinoma of the bladder
For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
Allergies: No known allergy to one of the study drugs
Patient Status:
No CNS metastases
No peripheral neuropathy > grade1
No other serious concomitant illness
Fully recovered from any prior therapy
Informed Consent: Patient and doctor have signed informed consent
Lower Age Limit: Lower age limit >18
Upper Age Limit: Upper Age Limit <70
ANC: ANC >1500/mm3 or WBC > 3000/mm3
Platelets: Platelets >100,000/mm3
Creatinine: Creatinine <1.8mg/dL
Bilirubin: Bilirubin <=2.0 x ULN
SGPT: SGPT (ALT) <=1.5 x ULN (<4xULN if liver metastases present)
RBC: Hemoglobin > 9.0g/dL
Cardiovascular: No active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months
Patients with metastatic cancer of the urothelial tract (TCC, Adenocarcinoma)
No prior exposure to Oxaliplatin
No cytotoxics or radiation 4 weeks prior to enrolling on protocol
PT/PTT normal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tolerability of the this combination in patients with recurrent metastatic bladder cancer. Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Sanofi-Synthelabo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria