Pyrazoloacridine in Treating Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002585
Recruitment Status : Completed
First Posted : August 11, 2004
Last Update Posted : March 12, 2012
National Cancer Institute (NCI)
Information provided by:
Barbara Ann Karmanos Cancer Institute

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 pyrazoloacridine in treating women with metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: pyrazoloacridine Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Primary Purpose: Treatment
Study Start Date : February 1994
Actual Primary Completion Date : October 1999
Actual Study Completion Date : January 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002585

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute Identifier: NCT00002585     History of Changes
Other Study ID Numbers: CDR0000063706
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2004    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: March 2012

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
NSC 366140
Antineoplastic Agents