Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT00041470
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
  • Vinorelbine — DRUG
    20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
  • Herceptin — DRUG
    4 mg/kg IV loading dose day 1 of first week followed by 2 mg/kg IV maintenance dose on each subsequent week. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
  • Filgrastim — DRUG
    5 mcg/kg daily including the day of IV chemotherapy. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.

Study Details

The purposes of this are: * To determine the highest doses of Taxol and Navelbine that we can safely give to patients; * To determine what kind of side effects are caused by the combination of Taxol, Navelbine and G-CSF; * To determine whether the combination of Taxol, Navelbine and G-CSF is more effective than standard therapy in treating metastatic breast cancer and prolonging life;

Key Dates

Start date
Mar 31, 2001
Status verified
Jun 2017
Primary completion
Aug 31, 2008
Completion
Aug 31, 2008

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Weekly paclitaxel, vinorelbine and GCSF
    Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Paclitaxel weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily

Primary Outcome Measure

To Measure Response Rates, Time to Progression and Survival in Patients so Treated. [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Cancer Care AllianceSeattleWashington98109-1023-

Find similar trials in Seattle, WA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Seattle Cancer Care Alliance· Seattle, WA

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