Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002585
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
1999-11-01
Brief Title:
Pyrazoloacridine in Treating Women With Metastatic Breast Cancer
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH METASTATIC BREAST CANCER
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
PURPOSE Phase II trial to study the effectiveness of pyrazoloacridine in treating women with metastatic breast cancer
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 cyclophosphamidedoxorubicinfluorouracil 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
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 cyclophosphamidedoxorubicinfluorouracil 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T94-0003H | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-C-1148-93 | None | None | None |