NCT00015886

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating women who have breast cancer that is metastatic or cannot be treated with surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2002

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 15, 2003

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

5.3 years

First QC Date

May 6, 2001

Last Update Submit

August 9, 2018

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancerstage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

  • To determine the response rate to this combination after two to four courses of Docetaxel (Taxotere) And 5-Fluorouracil

    28 weeks

Secondary Outcomes (1)

  • To evaluate toxicities of Docetaxel (Taxotere) And 5-Fluorouracil

    28 weeks

Interventions

docetaxelDRUG

75 milligrams per meter squared intraveneously

fluorouracilDRUG

350 milligrams intraveneously

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Metastatic or unresectable local disease * Measurable or evaluable disease * No ascites or pleural effusion as only metastatic site * No brain or leptomeningeal metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * 0-2 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count greater than 1,500/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * Bilirubin normal * SGOT/SGPT less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase less than 2.5 times ULN Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * Adequate cardiac function * No history of significant atherosclerotic coronary disease (e.g., uncontrolled angina) * No history of significant cardiac arrhythmia Other: * No serious medical or psychiatric illness that would preclude study * No active uncontrolled bacterial, viral, or fungal infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior high-dose chemotherapy and autologous transplantation Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No more than 2 prior chemotherapy regimens for metastatic breast cancer (in addition to adjuvant therapy) * No prior docetaxel * No prior high-dose chemotherapy and autologous transplantation * Prior paclitaxel allowed Endocrine therapy: * No concurrent hormonal therapy, except as contraception Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered * Concurrent radiotherapy for relief of localized pain or obstruction allowed Surgery: * At least 2 weeks since prior major surgery and recovered Other: * No other concurrent cytotoxic agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Palmetto Hematology/Oncology Associates

Spartanburg, South Carolina, 29303, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DocetaxelFluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gretchen Kimmick, MD, MS

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2001

First Posted

October 15, 2003

Study Start

January 1, 1997

Primary Completion

May 1, 2002

Study Completion

July 1, 2009

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

US(6)