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EPO906 Therapy in Patients with Advanced Breast Cancer



EPO906 Therapy in Patients with Advanced Breast Cancer

For Condition: Breast Neoplasms
Status: Suspended
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: This study will examine whether the investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause breast cancer.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria The following patients may be eligible for this study: - Histologically or cytologically documented evidence of disease with at least one measurable lesion; - Life expectancy of greater than three (3) months; - Patients who have had only one prior therapy for metastatic disease; - Patients who have received prior treatment with hormonal agents or who have had prior treatment regimens of radiotherapy in addition to one or no previous chemotherapy regimens are eligible; - Patients who have had no prior therapy for metastatic disease, but who have received a taxane and an anthracycline (single or combination therapy) as adjuvant treatment, are eligible. For patients who have had previous radiation therapy to the target lesion(s), the lesion(s) must since have demonstrated progression. Exclusion Criteria The following patients are not eligible for this study: - Bone-only disease; - Symptomatic pleural effusions; - Symptomatic CNS metastases or leptomeningeal involvement; - Any peripheral neuropathy or unresolved diarrhea greater than Grade 1; - Severe cardiac insufficiency; - Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports; - History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma ckin cancer or cervical cancer in situ; - Active or suspected acute or chronic uncontrolled infection including abcesses or fistulae; - HIV+ patients; - Pregnant or lactating females; - Patients who have had radiation, chemotherapy, or hormonal therapy within the last four (4) weeks excluding palliative radiotherapy to isolated peripheral bone metastases not being used as markers for efficacy; - Patients taking Herceptin less than three (3) weeks prior to study start.
Total Enrollment: 48

Location and Contact Information:

Cancer Institute of New Jersey (CINJ)
New Brunswick,  New Jersey,  08901
United States
 

Dartmouth Hitchcock Medical Center
Lebanon,  New Hampshire,  03756
United States
 


Additional Information:
Study ID Numbers:  CEPO906A-2205; 
Study Start Date: 
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035126

Other Breast Neoplasms Studies:
1. Phase I/II Study of Tamoxifen and Tipifarnib to Treat Advanced Breast Cancer

2. Phase III Study of Atamestane Plus Toremifene versus Letrozole in Advanced Breast Cancer

3. Sequential Vaccinations in Combination with Standard Adjuvant Chemotherapy in High-Risk Breast Cancer Patients Following Surgical Treatment

4. Antimetabolite Induction, High-Dose Alkylating Agent Consolidation and Retroviral Transduction of the MDR1 Gene into Peripheral Blood Progenitor Cells Followed by Intensification Therapy with Sequential Paclitaxel and Doxorubicin for Stage 4 Breast Cancer

5. Removal of the ovaries/fallopian tubes and CA-125 Screening to Reduce the Risk of Ovarian Cancer in Women at Increased Genetic Risk

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EPO906 Therapy in Patients with Advanced Breast Cancer
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