NCT00070252|CompletedPhase 1

Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer

Phase Ib/II Neoadjuvant Trial of the Farnesyltransferase Inhibitor, R115777 With Docetaxel and Capecitabine for Patients With Stage IIIA or IIIB Breast Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

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9 other identifiers

NCI-2012-01442WSU-C-2679MAYO-MC0131NCI-5599CDR0000331694MC01315599N01CM62205P30CA015083

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2003

StartedSep 2003

CompletionJun 2010

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Sep 2003

Longer than P75 for phase_1

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

September 1, 2003

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2003

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed

4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed

Last Updated

May 4, 2015

Status Verified

December 1, 2012

Enrollment Period

2.4 years

First QC Date

October 3, 2003

Last Update Submit

May 1, 2015

Conditions

Adult Solid Neoplasm Inflammatory Breast Carcinoma Male Breast Carcinoma Stage IIIA Breast Cancer Stage IIIB Breast Cancer

Outcome Measures

Primary Outcomes (2)

Dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)
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.
Up to 5 years

Secondary Outcomes (3)

Clinical tumor response (complete response [CR] or partial response [PR]) (Phase I)
Up to 5 years
Overall survival
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
Up to 5 years

Study Arms (1)

Treatment (tipifarnib, capecitabine, docetaxel)

EXPERIMENTAL

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: CapecitabineDrug: DocetaxelOther: Laboratory Biomarker AnalysisOther: Pharmacological StudyDrug: Tipifarnib