A Phase 1/2 interventional study of Capecitabine and Docetaxel in Adult Solid Neoplasm, Inflammatory Breast Carcinoma and Male Breast Carcinoma, sponsored by National Cancer Institute (NCI). Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-04.
Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment
Phase I/II 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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 53 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Histologically or cytologically confirmed solid tumor
No history of metastatic brain disease within the past 6 months
Histologically confirmed breast cancer
Invasive disease confirmed by 1 of the following*:
Hormone receptor status:
Phase Ib only:
Phase Ib and II:
Phase Ib only:
No prior capecitabine AND docetaxel (in combination or as single agents)
Phase II only:
Phase Ib only:
Phase II only:
Phase Ib only:
Phase II only:
Phase Ib only:
Phase Ib and II:
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. 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.
Drug: Capecitabine · Drug: Docetaxel · Other: Laboratory Biomarker Analysis · Other: Pharmacological Study · Drug: Tipifarnib
Given PO
Also known as: Ro 09-1978/000, Xeloda
Given IV
Also known as: RP56976, Taxotere, Taxotere Injection Concentrate
Correlative studies
Correlative studies
Given orally (PO)
Also known as: R115777, Zarnestra
Dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)
Time frame: 21 days
Pathologic complete response rate (Phase II)
Estimated by the number of patients with a complete pathologic response divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response probability will be calculated according to the approach of Duffy and Santner.
Time frame: Up to 5 years
Clinical tumor response (complete response [CR] or partial response [PR]) (Phase I)
Clinical responses will be summarized by simple descriptive summary statistics.
Time frame: Up to 5 years
Overall survival
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: From registration to death due to any cause, assessed up to 5 years
Toxicity as assessed by the National Cancer Institute (NCI) CTCAE version 3.0
Time frame: Up to 5 years
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)