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PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH METASTATIC BREAST CANCER


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH METASTATIC BREAST CANCER


OBJECTIVES: I. Assess the efficacy of pyrazoloacridine (PZA) administered by 3-hour infusion
in women with metastatic breast cancer. II. Assess the qualitative and quantitative
toxicities of PZA on this schedule. III. Assess the response duration and survival of
patients treated with this agent.

OUTLINE: All patients receive intravenous pyrazoloacridine (PZA) every 3 weeks in the
absence of progressive disease or unacceptable toxicity. Therapy continues in responding
patients until 6 months after a complete response or for 1 year, whichever is shorter;
stable patients receive a maximum of 4 courses. The dose is increased once for patients who
experience minimal toxicity. Patients who fail PZA are encouraged to continue therapy with
cyclophosphamide/doxorubicin/fluorouracil (CAF). All patients are followed for survival.
Prophylactic granulocyte colony-stimulating factor is not permitted.

PROJECTED ACCRUAL: Up to 20 patients will be accrued over 7-12 months. If no more than 1
response is seen in the first 12 evaluable patients, accrual will cease.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically documented breast adenocarcinoma Clinical or
radiologic evidence of metastatic disease required Histologic confirmation recommended if
evidence is equivocal Bidimensionally measurable disease required, i.e.: Lesion with
clearly defined margins on physical exam or radiologic evaluation with 1 diameter greater
than 0.5 cm Lytic bone metastases only if measurable on bone x-ray/survey Lesion
previously irradiated only if subsequent measurable progression New measurable lesion in
previously irradiated field The following are not considered measurable: Unidimensionally
measurable lesions Palpable nodal disease not measurable on CT Masses with margins not
clearly defined Lesions with both diameters less than 0.5 cm Bone disease other than lytic
bone disease Pleural effusions or ascites Disease identified by bone scan only History of
bilateral breast cancer allowed No brain metastases CT required if clinically indicated No
meningeal carcinomatosis Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Women only Menopausal status: Not specified
Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute
granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic:
Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL Other: No second
malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer
Adequately treated carcinoma in situ of the cervix Not pregnant or nursing Negative
pregnancy test required of premenopausal women Appropriate contraception required of
fertile women Blood/body fluid analyses to determine eligibility and physical exams for
tumor measurement completed within 7 days prior to registration; imaging studies to
evaluate and document measurable disease completed within 4 weeks prior to registration

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior chemotherapy for metastatic disease allowed At least 4 weeks since adjuvant
chemotherapy Endocrine therapy: Prior hormonal therapy allowed At least 4 weeks since
hormonal therapy for patients with partial or complete response to most recent maneuver
Radiotherapy: Prior radiotherapy for metastatic disease allowed At least 4 weeks since
radiotherapy and recovered Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patricia M. LoRusso, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000063706

NCT ID:

NCT00002585

Start Date:

February 1994

Completion Date:

January 2001

Related Keywords:

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

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201