Breast CancerPhase 2NCT00003041
Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
A Phase 2 study testing pyrazoloacridine in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 5 sites in United States.
Trial 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 who have refractory metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- pyrazoloacridine
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Jul 1997to Jan 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
Grant/Riverside Methodist Hospitals
Columbus, Ohio, 43214
Mount Carmel
Columbus, Ohio, 43222
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Central Baptist Hospital
Lexington, Kentucky, 40503
About this study
Official title: Phase II Evaluation of Pyrazoloacridine (NSC #366140) in Patients With Metastatic Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- pyrazoloacridine
- Keywords
- recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrazoloacridineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2004 (estimated)
- Study startJul 1997
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Eric H. Kraut, MD, Study chair, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003041
- Sponsor's protocol ID
- CDR0000065670
- Other IDs
- OSU-9712, NCI-T96-0120
- Status last verified
- Jan 2002
- First submitted
- 1 Nov 1999
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Pyrazoloacridine (NSC #366140) in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003041
- Acronym / sponsor ID
- CDR0000065670
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1997
- Study completion
- Jan 2002 (actual)
- First posted
- 23 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyrazoloacridine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric H. Kraut, MD study chair
Ohio State University Comprehensive Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pyrazoloacridine in people with Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.