Phase II Study of Oxaliplatin and Taxotere in Metastatic... | NCT00186277

Studies
Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer

NCT00186277

Sponsor

Stanford University

Status

Completed

Last Update Posted

Mar 30, 2011Estimated

Enrollment

10Actual

Phase

Phase 2

Conditions

Bladder Cancer

Interventions

Oxaliplatin
Taxotere

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BLDR0001	Other Identifier	Stanford University

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2011

Last Update Posted Date

Mar 30, 2011Estimated

Name	Class
Sanofi-Synthelabo	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxaliplatin	Drug	Calculated per patient		Eloxatin
Taxotere	Drug	Calculated per patient		Docetaxel

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dr. Sandy Srinivas	Stanford University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077150	Oxaliplatin
D000077143	Docetaxel

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes

Browse Leaves

Not provided

Browse Branches

Not provided