Tezacitabine and Oxaliplatin for the Treatment of Patient... | NCT00051688

Studies
Tezacitabine and Oxaliplatin for the Treatment of Patients With Metastatic Colorectal Cancer

NCT00051688

Sponsor

Chiron Corporation

Status

Terminated

Last Update Posted

Jul 11, 2006Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Colorectal Neoplasms

Interventions

tezacitabine
oxaliplatin

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

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2003

Primary Completion Date

Not provided

Completion Date

Aug 2004

First Submitted Date

Jan 15, 2003

First Submission Date that Met QC Criteria

Jan 15, 2003

First Posted Date

Jan 16, 2003Estimated

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

Jul 10, 2006

Last Update Posted Date

Jul 11, 2006Estimated

Description Module

Brief Summary

The primary purpose of this study is to determine the best dose of tezacitabine when combined with oxaliplatin in patients with metastatic colorectal cancer. This study will also evaluate tumor response to the combination of anti-cancer drugs.

Detailed Description

Not provided

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility Criteria

Patients with metastatic colorectal adenocarcinoma who have failed one prior course of chemotherapy.
Patients must have at least one measurable tumor.
Patients may not have received prior treatment with oxaliplatin.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ACRC/Arizona Clinical Research Center		Tucson	Arizona	85712	United States
USC/Norris Comprehensive Cancer Center

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C086432	tezacitabine
D000077150	Oxaliplatin

Ancestor Terms

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
tezacitabine	Drug
oxaliplatin	Drug