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Breast
Taxol and Herceptin
CALGB 9840: This phase-III study seeks to determine whether infusing paclitaxel (Taxol) weekly for one hour yields better results and fewer side effects than the standard three-hour infusion every three weeks. Therapy may also include Herceptin (trastuzumab), a monoclonal antibody that targets a growth-related receptor protein called her-2/neu. Patients whose cancers overexpress this receptor get Herceptin weekly as part of their treatment, while patients who are not overexpressors receive either paclitaxel alone or paclitaxel plus Herceptin.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0299-543
Chemotherapy and Herceptin
CALGB 49909: This phase-III trial seeks to determine if Herceptin should be added to current chemotherapy in the treatment of early-stage breast cancer that has spread to axillary lymph nodes. The trial is for women whose cancer is characterized by overexpression of the growth-related receptor protein her-2/neu.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Scott Wadler
0902-468
Epothilone for Metastatic Breast Cancer
163010-016: This phase-II study of the epothilone analog BMS-247550 is for patients with metastatic breast cancer who were previously treated with anthracycline. Epothilones are similar to taxanes (which include the drug Taxol, used to treat breast, ovarian, and lung cancer), but they have qualities that may make BMS-247550 work better, or work in cases where Taxol is not effective at all. Closed to accrual.
Principal Investigator: Dr. Linda Vahdat
CU14519
Epothilone for Metastatic Breast Cancer
163009-021: Phase-II study of epothilone-B analog BMS-247550 in patients with taxane-resistant metastatic breast cancer. The analog is a highly promising alternative to taxanes, a group that includes the drug Taxol. Closed to accrual.
Principal Investigator: Dr. Linda Vahdat
CU13916
Epothilone and Capecitabine for Metastatic Breast Cancer
163031-008: Phase-I study of the epothilone drug BMS-247550 in combination with capecitabine in patients with metastatic breast cancer previously treated with a taxane and anthracycline. Epithilones are highly promising alternatives to taxanes, while capecitabine (Xeloda) has been shown to enhance the effectiveness of several chemotherapeutic drugs.
This trial is currently on hold.
Principal Investigator: Dr. Linda Vahdat
CU14782
Zarnestra for Locally Advanced Cancer
NCI 5598: A phase-II study of 1) the post-operative effect of the experimental drug R115777 Zarnestra plus doxorubicin and cyclophosphamide and 2) the preoperative effect of R115777 Zarnestra plus docetaxel (Taxotere) in patients with locally advanced breast cancer. Zarnestra is one of a group of drugs known as farnesyl transferase inhibitors; they prevent the enzyme farnesyl transferase from activating a growth-promoting gene called ras, which has been implicated in many cancers.
Consortium study
Sponsor: National Cancer Institute
0902-491
Prevention of Bone Loss
CALGB 79809: Phase-III trial of intravenous zoledronic acid in the prevention of bone loss in localized breast cancer patients with chemotherapy-induced ovarian failure. Patients are randomized into two groups. Beginning on the first day of adjuvant chemotherapy, the first group receives oral calcium and vitamin D daily for 36 months and zoledronate intravenously every three months over 24 months. The second group receives calcium and vitamin D daily plus zoledronate intravenously every three months during months 13 to 36. Bone density in the lumbar spine is compared after 12 and 36 months.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal Investigator: Dr. Linda Vahdat
0103-637
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