Status:
COMPLETED
Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with gemcitabine hydrochloride and to see how well they work in treating women with breast cancer tha...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the objective response rate of the combination of gemcitabine (gemcitabine hydrochloride) and the farnesyltransferase inhibitor tipifarnib (R115777) in patients wit...
Eligibility Criteria
Inclusion
- Histologically confirmed breast cancer and clinical evidence of metastatic disease
- Patients may have received any number or type of hormonal therapies, either for stage IV disease and/or as adjuvant therapy; patients may have received trastuzumab therapy
- Patients may have received up to 2 prior chemotherapy regimens as therapy for metastatic breast cancer; patients must have recovered from the myelosuppressive effects of prior chemotherapy and all toxicity must have recovered to grade less than or equal to 1
- Concomitant bisphosphonates are allowed for patients with bone metastases
- Localized radiotherapy that does not influence the single evaluable lesion is allowed prior to the initiation of therapy; patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 4 weeks)
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral computed tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky \> 60%)
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 × institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- There should be a four-week delay between the conclusion of radiation and the start of gemcitabine, provided the acute effects of radiation treatment have resolved
Exclusion
- Prior therapy with farnesyltransferase inhibitor or gemcitabine for metastatic breast cancer
- Patients with leptomeningeal disease and/or brain metastasis
- Patients with symptomatic lymphangitic pulmonary metastases
- Patients with peripheral neuropathy greater than or equal to grade 2
- No history of concomitant malignancy except for non-melanoma skin cancer or cervical cancer in situ or other malignancy treated curatively and no evidence of disease for at least five years
- Patients who have had chemotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tipifarnib (R115777), or imidazole derivatives
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00100750
Start Date
September 1 2005
End Date
January 1 2010
Last Update
January 13 2015
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030