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

This study has been completed.
Sponsor:
Collaborators:
Amgen
Bristol-Myers Squibb
GlaxoSmithKline
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00041470
First received: July 9, 2002
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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;

Condition Intervention Phase
Breast Cancer
Drug: Paclitaxel
Drug: Vinorelbine
Drug: Trastuzumab
Drug: Filgrastim
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To measure the qualitative and quantitative toxicity of this regimen. [ Time Frame: <= 18 months ] [ Designated as safety issue: Yes ]
  • To measure response rates, time to progression and survival in patients so treated. [ Time Frame: <= 4 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2001
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Drug: Paclitaxel
50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Drug: Vinorelbine
20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.
Drug: 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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041470

Locations
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
University of Washington
Amgen
Bristol-Myers Squibb
GlaxoSmithKline
Investigators
Principal Investigator: Julie R. Gralow, M.D. University of Washington
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00041470     History of Changes
Other Study ID Numbers: 00-5891
Study First Received: July 9, 2002
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vinorelbine
Paclitaxel
Trastuzumab
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014