Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

NCT ID: NCT00186277

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxaliplatin

Calculated per patient

Intervention Type DRUG

Taxotere

Calculated per patient

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eloxatin Docetaxel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi-Synthelabo

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stanford University School of Medicine

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr. Sandy Srinivas

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BLDR0001

Identifier Type: OTHER

Identifier Source: secondary_id

BLDR0001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

XELOX for Metastatic Breast Cancer
NCT00204776 COMPLETED PHASE2