NCT00026442

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of two different doses of capecitabine in treating women who have advanced or metastatic breast cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

10 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

April 1, 2004

First QC Date

November 9, 2001

Last Update Submit

December 17, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Interventions

capecitabineDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically and/or cytologically confirmed breast cancer * Advanced and/or metastatic disease * At least 1 measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.25 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present) * Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present OR 10 times ULN if bone metastases present) * No hepatitis Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 50 mL/min Cardiovascular: * No clinically significant cardiac disease * No congestive heart failure * No symptomatic coronary artery disease * No cardiac arrhythmias poorly controlled with medication * No myocardial infarction within the past 12 months even if adequately controlled with medication Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No severe pain inadequately controlled by analgesics * No prior severe and unexpected reaction to fluoropyrimidine therapy * No known hypersensitivity to fluorouracil * No impaired physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * No inability to swallow tablets * No history of uncontrolled seizures, central nervous system disorder, or psychiatric disability that would preclude study participation * No serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 2 but no more than 3 prior chemotherapy regimens * At least 1 prior chemotherapy regimen containing paclitaxel and an anthracycline as adjuvant therapy or for advanced and/or metastatic disease Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to target lesions unless there is evidence of new disease within the irradiated field * No concurrent radiotherapy Surgery: * No prior organ allografts Other: * At least 4 weeks since prior investigational drug * No concurrent enrollment on other investigational study * No other concurrent anticancer agents

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

Sponsors & Collaborators

Study Sites (10)

Antelope Valley Hospital

Lancaster, California, 93534, United States

Location

Medical Oncology Care Associates

Orange, California, 92868, United States

Location

California Cancer Medical Center

West Covina, California, 91790, United States

Location

Oncology Clinic, P.C.

Colorado Springs, Colorado, 80907, United States

Location

Hematology Oncology Associates of theTreasure Coast - Port St. Lucie

Port Saint Lucie, Florida, 34952, United States

Location

North Florida Cancer Center

Saint Augustine, Florida, 32086, United States

Location

Maryland Hematology/Oncology Associates

Baltimore, Maryland, 21236, United States

Location

Charleston Hematology-Oncology, P.A.

Charleston, South Carolina, 29403, United States

Location

Family Cancer Center

Collierville, Tennessee, 38017, United States

Location

Logan Regional Hospital

Logan, Utah, 84341, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Sandy Marcus

    Pharmatech Oncology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2001

First Posted

January 27, 2003

Study Start

November 1, 2001

Last Updated

December 18, 2013

Record last verified: 2004-04

Locations

US(10)