Temozolomide in Treating Women With Advanced Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005054
First received: April 6, 2000
Last updated: September 19, 2013
Last verified: January 2001
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: temozolomide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Temodal 4 Hourly in Progressive Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005054

Locations
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Sponsors and Collaborators
Christie Hospital NHS Foundation Trust
Investigators
Study Chair: Anthony Howell, MD Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005054     History of Changes
Other Study ID Numbers: CDR0000067649, CHNT-H98-198-50, EU-99047
Study First Received: April 6, 2000
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014