Pyrazoloacridine in Treating Women With Metastatic Breast Cancer

NCT00002585 | Completed Phase 2

• 4 other identifiers: CDR0000063706P30CA022453WSU-C-1148-93NCI-T94-0003H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

pyrazoloacridine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

NSC 366140

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patricia M. LoRusso, DO

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 11, 2004
• Study Start: February 1, 1994
• Primary Completion: October 1, 1999
• Study Completion: January 1, 2001
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

US (1)