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Breast CancerPhase 2NCT00002585

Pyrazoloacridine in Treating Women With Metastatic Breast Cancer

A Phase 2 study testing pyrazoloacridine in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 with metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
pyrazoloacridine
How many people
20 participants
Where
1 siteUnited States
Study dates
Feb 1994to Jan 2001
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE 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 with metastatic breast cancer.

Read the 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.

Conditions
Breast Cancer
Being tested
pyrazoloacridine
Keywords
stage IV breast cancer, 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.

  1. First posted11 Aug 2004 (estimated)
  2. Study startFeb 1994
  3. Primary completionOct 1999
  4. Study completionJan 2001

Resources

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
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002585
Sponsor's protocol ID
CDR0000063706
Other IDs
P30CA022453, WSU-C-1148-93, NCI-T94-0003H
Status last verified
Mar 2012
First submitted
1 Nov 1999
Last updated
12 Mar 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pyrazoloacridine in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site 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 12 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 12 Mar 2012.

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