Ignite Creation Date:
2024-05-05 @ 9:45 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002837
Status:
COMPLETED
Last Update Posted:
2012-07-31
First Post:
1999-11-01
Brief Title:
High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I-II Study of Dose Intense Doxorubicin Paclitaxel And Cyclophosphamide With Peripheral Blood Progenitor Cells PBPC And Cytokine Support In Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-07
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 Combining peripheral stem cell transplantation with chemotherapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients with recurrent or metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients with recurrent or metastatic breast cancer
Detailed Description:
OBJECTIVES I Define the maximum tolerated doses of four courses of doxorubicin DOX paclitaxel TAX and cyclophosphamide CTX followed by peripheral blood stem cell PBSC and granulocyte colony-stimulating factor support given in an out-patient setting in patients with metastatic breast cancer II Evaluate the cardiotoxicity of the combination of bolus DOX a 3-hour infusion of TAX and CTX III Determine the clinical response rate and time to progression associated with this regimen IV Determine Cmax AUC and the drugmetabolite ratio of TAX and DOX when given with CTX a known p450 inducer
OUTLINE Patients without prior doxorubicin DOX or paclitaxel TAX receive two courses of induction chemotherapy with DOXTAX with G-CSF support given 3 weeks apart Peripheral blood stem cells PBSC are harvested during the recovery phase following the second course Patients who previous received DOX or TAX and responded receive cyclophosphamide CTX with G-CSF for stem cell mobilization followed by PBSC harvest Back-up bone marrow may be harvested from patients without marrow involvement for whom PBSC collection is inadequate Patients with responding or stable disease who have adequate PBSC available receive dose-intensive chemotherapy with DOX CTX and TAX given on day 1 with PBSC infused on day 3 and G-CSF given from day 3 until neutrophil recovery Four courses of dose-intensive chemotherapy with PBSC and G-CSF support are given every 3-4 weeks During the phase I portion of the study groups of 3-6 patients are treated at increasing doses of DOX TAX and CTX until the maximum tolerated dose MTD is determined during the phase II portion additional patients are treated at the MTD Patients who progress after 2 courses of induction or 2 courses of dose-intensive chemotherapy are given the option of receiving their PBSC after conditioning with a different regimen eg CTX etoposide and cisplatin Patients who receive induction on protocol but who choose not to receive dose-intensive chemotherapy continue DOXTAX for a total of 6 courses Patients are followed 3 6 12 18 and 24 months after therapy then as clinically indicated
PROJECTED ACCRUAL During the phase I portion of the study groups of 3-6 patients will be entered at each dose level studied During the phase II portion of the study 25 patients will be treated at the maximum tolerated dose
OUTLINE Patients without prior doxorubicin DOX or paclitaxel TAX receive two courses of induction chemotherapy with DOXTAX with G-CSF support given 3 weeks apart Peripheral blood stem cells PBSC are harvested during the recovery phase following the second course Patients who previous received DOX or TAX and responded receive cyclophosphamide CTX with G-CSF for stem cell mobilization followed by PBSC harvest Back-up bone marrow may be harvested from patients without marrow involvement for whom PBSC collection is inadequate Patients with responding or stable disease who have adequate PBSC available receive dose-intensive chemotherapy with DOX CTX and TAX given on day 1 with PBSC infused on day 3 and G-CSF given from day 3 until neutrophil recovery Four courses of dose-intensive chemotherapy with PBSC and G-CSF support are given every 3-4 weeks During the phase I portion of the study groups of 3-6 patients are treated at increasing doses of DOX TAX and CTX until the maximum tolerated dose MTD is determined during the phase II portion additional patients are treated at the MTD Patients who progress after 2 courses of induction or 2 courses of dose-intensive chemotherapy are given the option of receiving their PBSC after conditioning with a different regimen eg CTX etoposide and cisplatin Patients who receive induction on protocol but who choose not to receive dose-intensive chemotherapy continue DOXTAX for a total of 6 courses Patients are followed 3 6 12 18 and 24 months after therapy then as clinically indicated
PROJECTED ACCRUAL During the phase I portion of the study groups of 3-6 patients will be entered at each dose level studied During the phase II portion of the study 25 patients will be treated at the maximum tolerated dose
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 |
|---|---|---|---|
| CDR0000065052 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-DM-95156 | OTHER | None | None |
| NCI-V96-1017 | None | None | None |