Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070252
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2003-10-03
Brief Title:
Neoadjuvant Tipifarnib Docetaxel and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IbII Neoadjuvant Trial of the Farnesyltransferase Inhibitor R115777 With Docetaxel and Capecitabine for Patients With Stage IIIA or IIIB Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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:
Phase III trial to study the effectiveness of neoadjuvant tipifarnib combined with docetaxel and capecitabine in treating patients who have locally advanced or metastatic solid tumors or stage IIIA or stage IIIB breast cancer Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth Drugs used in chemotherapy such as docetaxel and capecitabine use different ways to stop tumor cells from dividing so they stop growing or die Combining tipifarnib with docetaxel and capecitabine may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose and recommended dose of capecitabine in combination with docetaxel and tipifarnib in patients with locally advanced or metastatic solid tumors Phase Ib II Determine the complete pathological and clinical response rate in patients with stage IIIA or IIIB breast cancer treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine disease-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of capecitabine Patients in phase II are stratified according to type of breast cancer inflammatory vs noninflammatory
Phase Ib Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oral tipifarnib twice daily for 6 days Beginning at least 48 hours after completion of the initial dose of tipifarnib patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine Patients in phase Ib are followed at 3 months
Patients in phase II are followed every 4 months for up to 5 years
PROJECTED ACCRUAL A total of 24-53 patients 9-18 for phase Ib and 15-35 for phase II will be accrued for this study within 14-35 months
I Determine the maximum tolerated dose and recommended dose of capecitabine in combination with docetaxel and tipifarnib in patients with locally advanced or metastatic solid tumors Phase Ib II Determine the complete pathological and clinical response rate in patients with stage IIIA or IIIB breast cancer treated with this regimen Phase II
SECONDARY OBJECTIVES
I Determine the toxicity of this regimen in these patients II Determine disease-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of capecitabine Patients in phase II are stratified according to type of breast cancer inflammatory vs noninflammatory
Phase Ib Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14 and docetaxel IV over 30-60 minutes on days 1 and 8 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive oral tipifarnib twice daily for 6 days Beginning at least 48 hours after completion of the initial dose of tipifarnib patients receive treatment as in phase Ib for up to 6 courses at the MTD of capecitabine Patients in phase Ib are followed at 3 months
Patients in phase II are followed every 4 months for up to 5 years
PROJECTED ACCRUAL A total of 24-53 patients 9-18 for phase Ib and 15-35 for phase II will be accrued for this study within 14-35 months
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 |
|---|---|---|---|
| P30CA015083 | NIH | CTEP | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2012-01442 | REGISTRY | None | None |
| WSU-C-2679 | None | None | None |
| MAYO-MC0131 | None | None | None |
| NCI-5599 | None | None | None |
| CDR0000331694 | None | None | None |
| MC0131 | OTHER | None | None |
| 5599 | OTHER | None | None |
| N01CM62205 | NIH | None | None |