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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041470
• Other study ID #: 00-5891
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 9, 2002
• Last updated: September 13, 2012
• Start date: March 2001
• Est. completion date: August 2008

Study information

• Verified date: September 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION

To be eligible, volunteers must:

• Have stage IV carcinoma of the breast that has been microscopically confirmed

• Be age > 18

• Be fully active or ambulatory with symptoms but able to do light work

• Have a life expectancy of > 16 weeks

• Be > 2 weeks from prior surgery; > 3 weeks from radiation therapy to the pelvis, spine or long bones; > 3 weeks from prior chemotherapy (> 6 weeks for mitomycin C or nitrosureas) and > 2 weeks from prior hormonal therapy

• Have had one or less prior regimens for metastatic disease

• Have measurable (bidimensionally) or evaluable disease that is in an area that has not been radiated

EXCLUSION

Patients are not eligible if they:

• Have rapidly progressing liver or lung metastases or uncontrolled central nervous system metastases

• Are medically unstable

• Are pregnant, nursing or unwilling to employ adequate contraception

• Have pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer

• Have psychological, familial, sociological or geographical conditions that do not permit weekly medical follow-up and compliance with the study protocol

• Have hypersensitivity to E. Coli-derived proteins, Filgrastim, or any of its components

• Have had prior therapy with Navelbine

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Paclitaxel
50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
• Vinorelbine
20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
• Trastuzumab
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
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.

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	Amgen, Bristol-Myers Squibb, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the qualitative and quantitative toxicity of this regimen.		<= 18 months	Yes
Primary	To measure response rates, time to progression and survival in patients so treated.		<= 4 years	No