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Continuous Temozolomide (SCH 52365) in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer, Phase II

Phase 2
18 Years
Not Enrolling
Breast Cancer, Soft Tissue Sarcoma

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Trial Information

Continuous Temozolomide (SCH 52365) in Patients With Advanced or Metastatic Soft Tissue Sarcoma or Metastatic Breast Cancer, Phase II

Because repeated dosing of temozolomide correlates with an improved response, which may be
due to progressive depletion of the enzyme AT, our hope is that a daily oral schedule will
be the most active schedule of this agent. In phase I studies doses below 85 mg/m2/day
continuously have been well-tolerated. We plan to begin dosing at 75 mg/m2/day for 6 weeks
out of an 8 week cycle and to escalate to 85 and 100 mg/m2/day in patients who have no grade
3/4 toxicity.

The purpose of this study is to determine whether treatment with temozolomide can effect the
survival of patients with advanced breast cancer or soft tissue sarcoma. To do this we will
assess the response rate, time to progression, and survival in patients with advanced breast
cancer or soft tissue sarcoma who are treated with temozolomide.

Inclusion Criteria:

Patients must have either:

- Stage IV, microscopically-confirmed carcinoma of the breast with:

- Relapse or progression while receiving, or within 12 months of having received,
an anthracycline-containing (doxorubicin or mitoxantrone) or taxane-containing
(paclitaxel or docetaxel) regimen as either adjuvant treatment or therapy for
advanced breast cancer, or

- Treatment to a maximum dose of anthracycline (e.g., greater than 450 mg/m2 of
doxorubicin), or

- A dose-limiting toxicity from a taxane, or

- An ECOG performance status of 2.

- OR —

- Unresectable or metastatic, microscopically-confirmed soft tissue sarcoma, that is
not amenable to treatment with Adriamycin or Ifosfamide due to:

- Poor cardiac reserve, or

- Poor performance status (ECOG performance status = 2) or

- Having failed treatment with Adriamycin or reached dose-limiting toxicity from

Patients must have histologic slides and/or blocks must be available for review.

Patients must have measurable (bidimensionally) or evaluable disease.

Patients must be 18 years old or older.

Patients must have Karnofsky Performance Status greater than 70% (ECOG less than 2) at
screen and on the first day of treatment.

Patients must have a life expectancy more than 16 weeks.

Patients must be informed consent must be obtained prior to enrollment.

Patients must be more than 2 weeks from prior surgery; more than 3 weeks from radiation
therapy to the pelvis, spine or long bones; more than 3 weeks from prior chemotherapy
(more than 6 weeks for mitomycin C or nitrosureas), or more than 2 weeks from prior
hormonal therapy.

Exclusion Criteria:

Granulocytes less than 1,500/mm3.

Platelet count less than 100,000/mm3.

Hemoglobin less than 10 gm/dl.

Creatinine greater than 2.0 mg/dl.

Total bilirubin greater than ULN (institutional upper limit of normal).

Visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung
metastases (i.e. patients whose disease is beyond control).

Medically unstable (i.e. with uncontrolled disease); diagnosis of other systemic cancer.

Pregnancy or lactation; failure to employ adequate contraception.

Uncontrolled CNS disease.

Greater than 30% marrow previously irradiated.

Psychological, familial, sociological or geographical conditions which do not permit
weekly medical follow-up and compliance with the study protocol.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

<= 78 months

Principal Investigator

James Butrynski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Institutional Review Board

Study ID:




Start Date:

July 2000

Completion Date:

December 2006

Related Keywords:

  • Breast Cancer
  • Soft Tissue Sarcoma
  • Breast cancer
  • Soft tissue sarcoma
  • Breast Neoplasms
  • Sarcoma



University of Washington/Seattle Cancer Care Alliance Seattle, Washington  98109