A Phase II Study of Paclitaxel, UFT, and Leucovorin in Pa... | NCT00037089

Studies
A Phase II Study of Paclitaxel, UFT, and Leucovorin in Patients With Metastatic Esophageal Cancer

NCT00037089

Sponsor

Edelman, Martin, M.D.

Status

Unknown status

Last Update Posted

Jun 24, 2005Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Esophageal Neoplasm

Interventions

UFT (Tegafur/Uracil)

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
UMCC 0110g

Status Module

Record Verification Date

Jan 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 14, 2002

First Submission Date that Met QC Criteria

May 14, 2002

First Posted Date

May 15, 2002Estimated

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

Jun 23, 2005

Last Update Posted Date

Jun 24, 2005Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Description Module

Brief Summary

This study is for patients with esophageal cancer that has spread to other areas. The purpose of this study is to:

Determine how well a combination of taxol, UFT, and leucovorin work in these patients,
Determine the survival of patients with metastatic esophageal carcinoma treated with this combination of drugs.
Identify the side effects of this drug combination.

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

Name	Type	Description	Arm Group Labels	Other Names
UFT (Tegafur/Uracil)	Drug

Eligibility Module

Eligibility Criteria

INCLUSION

Histologic proof of esophageal cancer
No more than one prior non-taxane chemotherapy regimen for either treatment of localized disease or metastatic disease AND they may not have received a regimen containing low dose continuous infusion of 5-FU (i.e. >5 days of infusion/cycle), capecitabine or UFT
No prior therapy with UFT+/-leucovorin, a taxane, capecitabine, low dose continuous infusion of 5-FU or ethynyl uracil.
Radiographic or physical examination documentation of metastatic disease
No major surgery within the 2 weeks preceding the start of treatment and fully recovered from any complications of surgery
No radiation within 2 weeks of beginning chemotherapy.
No chemotherapy within 4 weeks of beginning treatment.
Patients must wait at least 6 weeks after receiving BCNU or Mitomycin-C.
Minimum life expectancy of 3 months
Informed consent given
Laboratory values within limits set by study.

EXCLUSION

More than one prior chemotherapy regimen for metastatic disease
Current serious medical or psychiatric illness that would prevent informed consent or intensive treatment
>grade 1 peripheral sensory or motor neuropathy
Pregnant
Patient is taking the drug Sorivudine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland Cancer Center		Baltimore	Maryland	21201	United States

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005641	Tegafur
D014498	Uracil

Ancestor Terms

ID	Term
D005472	Fluorouracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided