NCT00194740

Taxotere Plus Weekly Navelbine and G-CSF: A Study in Stage IV Breast Cancer

Taxotere Plus Weekly Navelbine and G-CSF: A Phase II Study in Stage IV Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The two drugs used to treat metastatic breast cancer in this study may perform better when used together than when used separately. The use of another drug that prevents the most common side effect of the two-drug combination permits the delivery of both agents at closer to the "full" dose for either when used alone. We hypothesize that the two-drug combination used with G-CSF support will be more effective and less toxic than other standard regimens for the treatment of metastatic breast cancer.

Detailed description

Preclinical data suggest that there may be synergy between vinorelbine and paclitaxel when the two drugs are used in combination such that the effect of the two together may be better than either alone. Clinical data suggest that the use of concurrent G-CSF with paclitaxel and vinorelbine permits the delivery of both agents at approximately 70% of the "full" dose for either, used alone without G-CSF support, with myelosuppression as the usual dose-limiting toxicity and no unusual or unexpected complications. Encouragingly, 8/20 (40%) patients had objective responses, with three complete remissions (15%) in this program of third-line therapy. Therefore, we now propose to combine docetaxel at about 70% of "full" dose with vinorelbine at 27.5 mg/m2, the "phase II" dose defined in the previous trial. Docetaxel will be given on day 1 followed by vinorelbine on days 8 and 15, with G-CSF to be administered on all days except that of docetaxel administration. The cycle is to be repeated every three weeks.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	Docetaxel	60 mg/m2, IV, day 1 of each 21 day cycle
DRUG	Vinorelbine	27.5 mg/m2, IV, days 8 \& 15 of each 21 day cycle
DRUG	Filgrastim	5 µg/kg/day s.c., to be administered days 2-21 of each cycle.

Timeline

• Start date: 1997-11-01
• Completion: 2007-06-01
• First posted: 2005-09-19
• Last updated: 2007-12-06

Locations

1 site across 1 country: United States