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Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003041
First Posted: April 23, 2004
Last Update Posted: January 31, 2013
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 who have refractory metastatic breast cancer.


Condition Intervention Phase
Breast Cancer Drug: pyrazoloacridine Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Evaluation of Pyrazoloacridine (NSC #366140) in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1997
Study Completion Date: January 2002
Detailed Description:

OBJECTIVES: I. Determine the efficacy of pyrazoloacridine in patients with refractory breast cancer. II. Determine the toxic effects of pyrazoloacridine in these patients.

OUTLINE: Patients receive pyrazoloacridine IV over 3 hours. Treatment repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 1 year.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally measurable disease of any of the following types required: Bidimensionally measurable lung lesions on chest X-ray, CT scan, or MRI Palpable and quantifiable lymph nodes at least 2 x 2 cm Abdominal mass at least 2 x 2 cm quantifiable by CT scan Bidimensionally measurable liver metastases at least 2 x 2 cm Palpable hepatomegaly if liver edge is clearly defined and extends at least 5 cm below the costal margin of the xiphoid process Unacceptable as measurable disease: Diffuse lung infiltration or unidimensionally measurable hilar lesions Pelvic mass of indefinite dimension Bone metastases Pleural effusion or ascites No brain metastases Must have failed or progressed on prior therapy or relapsed less than 12 months after therapy discontinuation Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 16 and over Sex: Female Menopausal status: Not specified Performance status: SWOG 0-2 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of congestive heart failure, myocardial infarction within past 6 months, ventricular arrhythmia, or ischemic heart disease requiring medication If necessary, ejection fraction at least 50% by MUGA Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior malignancies in past 5 years other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No other serious illnesses or active infections No seizure disorder requiring anticonvulsant therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens for metastatic disease One prior adjuvant chemotherapy regimen for metastatic disease allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: One prior regimen of hormonal therapy for metastatic disease allowed At least 3 weeks since prior hormonal therapy and recovered No concurrent hormonal or corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: At least 4 weeks since any prior treatment directed at the tumor and recovered No other concurrent anticancer or investigational therapy No concurrent participation on another therapeutic clinical trial

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00003041


Locations
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Grant/Riverside Methodist Hospitals
Columbus, Ohio, United States, 43214
Mount Carmel
Columbus, Ohio, United States, 43222
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Eric H. Kraut, MD Ohio State University Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00003041     History of Changes
Other Study ID Numbers: CDR0000065670
OSU-9712
NCI-T96-0120
First Submitted: November 1, 1999
First Posted: April 23, 2004
Last Update Posted: January 31, 2013
Last Verified: January 2002

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer

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