NCT00005054

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating women who have advanced 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

1 active site

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

May 1, 1998

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

June 8, 2004

Completed
Last Updated

September 20, 2013

Status Verified

January 1, 2001

First QC Date

April 6, 2000

Last Update Submit

September 19, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancer

Interventions

temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven advanced carcinoma of the breast with documented progression on first line chemotherapy Measurable disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST no greater than 3 times ULN Alkaline phosphatase less than 2 times ULN unless arising from bone Renal: Creatinine less than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other clinically significant disease that would interfere with study evaluations No uncontrolled vomiting that would preclude administration of oral medications HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy and recovered Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy Surgery: Recovered from prior surgery Other: No other concurrent experimental drugs

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

Sponsors & Collaborators

Study Sites (1)

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Anthony Howell, MD

    The Christie NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2000

First Posted

June 8, 2004

Study Start

May 1, 1998

Last Updated

September 20, 2013

Record last verified: 2001-01

Locations

GB(1)