- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00077363
Capecitabine and Tipifarnib in Treating Women With Taxane-Resistant Metastatic Breast Cancer
A Phase II Trial of Capecitabine in Combination With the Farnesyltransferase Inhibitor, R115777 (Tipifarnib, Zarnestra) in Patients With Metastatic Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. The primary objective of this study is to determine the response rate in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
SECONDARY OBJECTIVES:
I. To evaluate toxicity in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
II. To evaluate progression free survival, time to treatment failure, and overall survival in patients with taxane-resistant metastatic breast cancer treated with capecitabine plus tipifarnib.
OUTLINE: This is a multicenter study.
Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Eastern Cooperative Oncology Group
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female patients with histologically confirmed adenocarcinoma of the breast with manifestations of metastatic progression
- Patients must have at least one objective measurable disease parameter as defined by RECIST criteria; tumor measurements and evaluation of non-measurable sites must be performed within 4 weeks prior to registration
- ECOG performance status 0-2
- In order to be eligible for inclusion, patients must meet all of the following criteria with regard to prior cytotoxic therapy: (1) prior treatment with an anthracycline (e.g., doxorubicin, epirubicin) either in the adjuvant/neoadjuvant setting and/or for metastatic disease, (2) prior treatment with a taxane (i.e. paclitaxel, docetaxel) for metastatic disease, or relapse while receiving adjuvant taxane therapy (3) progressive disease while receiving taxane therapy or up to 30 days after receiving the last taxane dose, (4) no more than three prior cytotoxic regimens for metastatic disease, (5) no prior treatment with capecitabine or 5-flourouracil for metastatic disease
- Prior hormonal therapy in either the metastatic or adjuvant/neoadjuvant setting is allowed, but patients must have been off such therapy for greater than or equal to 1 week prior to registration
No prior radiotherapy other than to the conserved breast, to the postmastectomy chest wall or to a limited field involving less than 25% of marrow - containing bone
- Previously irradiated tumors cannot be used to assess a clinical response; patients will not be eligible for this study if the previously irradiated tumors constitute the only site of measurable disease
- Patients must not have previously received tipifarnib or other farnesyl transferase inhibitors
- Patients must be disease-free of prior malignancies for > 5 years with the exception of curatively treated basal or squamous cell carcinomas of the skin or carcinoma in situ of the cervix
- Patients must have serum creatinine =< 1.5 mg/dl or measured (or calculated) creatinine clearance >= 60 mL/minute
- Granulocytes > 1500/mm^3
- Platelets > 100,000/mm^3
- Total bilirubin =< 1.5 x upper limit of normal
- SGOT (AST) and SGPT (ALT) =< 3 x upper limit of normal (unless liver is involved by tumor, in which case SGOT (AST) and SGPT (ALT) can be =< 5 x upper limit of normal)
- Patients must not be pregnant or breastfeeding since there is no information regarding the use of these agents in this population; a negative serum or urine pregnancy test is required within 14 days prior to registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration)
- Women of childbearing potential are strongly advised to use an accepted and effective method of contraception
- Patients with current or previously treated brain metastases are ineligible; patients who are taking enzyme inducing anticonvulsant medications are also not eligible (e.g., phenobarbital, phenytoin)
- Patients must not have had prior organ allograft or received immunosuppressive therapy
- Patients must not have any uncontrolled intercurrent illness including, but not limited to, chronic nausea/vomiting, complete or partial bowel obstruction, dysphagia/odynophagia with inability to swallow pills, ongoing or active infection, symptomatic cardiovascular disease, or other chronic medical or psychiatric conditions that would impair compliance or would substantially increase the risk of participating in this study
- Patients must not have received previous treatment with cytotoxic drugs, and/or radiotherapy < 4 weeks prior to registration; concurrent radiation therapy is not permitted
- Because of the potential for a drug interaction between warfarin and both tipifarnib and capecitabine, patients taking warfarin adjusted to an elevated INR are not eligible; patients taking prophylactic low-dose warfarin (i.e., 1 mg daily) are eligible, but a PT and INR are required within 2 weeks of registration and must be normal
- Patients with CTC v 3.0 grade 2-4 neuropathy are not eligible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (tipifarnib, capecitabine)
Patients receive oral tipifarnib twice daily and oral capecitabine twice daily on days 1-14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response (CR) receive 4 additional courses beyond documentation of CR.
|
Given PO
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (PR+CR)
Time Frame: Up to 5 years
|
Up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: From registration to progression or to death from any cause without documentation of progression, assessed up to 5 years
|
The Kaplan-Meier method will be used to estimate distributions.
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From registration to progression or to death from any cause without documentation of progression, assessed up to 5 years
|
Time to treatment failure (TTF)
Time Frame: From registration to disease progression, permanent discontinuation of treatment due to toxicity, or death, whichever occurs first, assessed up to 5 years
|
The Kaplan-Meier method will be used to estimate distributions.
|
From registration to disease progression, permanent discontinuation of treatment due to toxicity, or death, whichever occurs first, assessed up to 5 years
|
Overall survival (OS)
Time Frame: Up to 5 years
|
The Kaplan-Meier method will be used to estimate distributions.
|
Up to 5 years
|
Incidence of toxicities
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Gradishar, Eastern Cooperative Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02973
- U10CA021115 (U.S. NIH Grant/Contract)
- E1103
- CDR0000350219 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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