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Phase II Trial of Temodal 4 Hourly in Progressive Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II Trial of Temodal 4 Hourly in Progressive Breast Cancer

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Anthony Howell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Christie Hospital NHS Foundation Trust


United States: Federal Government

Study ID:




Start Date:

May 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms