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Temozolomide in Treating Women With Advanced Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
temozolomide
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Christie Hospital N.H.S. Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
September 19, 2013
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00005054
Brief Title
Temozolomide in Treating Women With Advanced Breast Cancer
Official Title
Phase II Trial of Temodal 4 Hourly in Progressive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Assess the therapeutic activity of temozolomide in terms of tumor response, progression free and overall survival in women with advanced breast cancer. II. Assess the extent of ATase depletion and DNA methylation in the peripheral blood of these patients undergoing this regimen and investigate the relationship between these parameters and tumor response. OUTLINE: Patients receive oral temozolomide every 4 hours for a total of 5 doses. Treatment continues every 28 days for a minimum of 2 courses and a maximum of 1 year in the absence of unacceptable toxicity or disease progression. Patients are followed at 30 days, and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Howell, MD
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

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Temozolomide in Treating Women With Advanced Breast Cancer

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