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

December 3, 2007 updated by: University of Washington

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • University of Washington/Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have stage IV, microscopically-confirmed carcinoma of the breast with histologic slides and/or blocks available for review.
  • Patients must have relapse or progression while receiving, or within 12 months of having received, anthracycline-containing (doxorubicin or mitoxantrone) regimen as either adjuvant treatment or therapy for advanced breast cancer. Prior Taxol by 3- or 24-hour infusion is permitted. Patients who have received a maximum dose of anthracycline (greater than 450 mg/m2) are also eligible.
  • Patients must have measurable (bidimensionally) or evaluable disease.
  • Patients must be 18 or more years of age.
  • Patients must have a Karnofsky Performance Status greater than or equal to 70% at screen and on the first day of treatment.
  • Patients must have a life expectancy of more than 16 weeks.
  • Prior irradiation is permitted, provided that prior irradiation does not exceed 25% of the estimated bone marrow volume and provided that measurable/evaluable disease exists outside the radiation field OR there must be histologic proof of progressive disease within a radiation field.
  • Informed consent must be obtained prior to registration.
  • Patients must be more than 2 weeks from prior surgery; more than 3 weeks from radiation therapy to the pelvis, spine or long bones; more than 3 weeks from prior chemotherapy (more than 6 weeks for mitomycin C or nitrosureas), or more than 2 weeks from prior hormonal therapy.
  • All patients must have appropriate central venous access.

Exclusion Criteria:

Patients are excludes if their:

  • Granulocyte count is less than 1,500/mm3.
  • Platelet count is less than 100,000/mm3.
  • Hemoglobin is less than 9 gm/dl.
  • Creatinine is greater than 2.0 mg/dl.
  • Total bilirubin is greater than ULN (institutional upper limit of normal)..
  • SGOT (AST) and/or SGPT (ALT) is greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN.

Patients are excluded if they are:

  • In visceral crisis characterized by rapidly progressive hepatic or lymphangitic lung metastases.
  • Medically unstable.
  • Pregnant or lactating.

Patients are excluded if they have:

  • Uncontrolled CNS disease.
  • Pre-existing clinically significant peripheral neuropathy except for abnormalities due to cancer.
  • Psychological, familial, sociological or geographical conditions which do not permit weekly medical follow-up and compliance with the study protocol.
  • Prior therapy with Navelbine.
  • Sensitivity to E. Coli-derived proteins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Docetaxel
60 mg/m2, IV, day 1 of each 21 day cycle
Other Names:
  • Taxotere
Drug: Vinorelbine
27.5 mg/m2, IV, days 8 & 15 of each 21 day cycle
Other Names:
  • Navelbine
Drug: Filgrastim
5 µg/kg/day s.c., to be administered days 2-21 of each cycle.
Other Names:
  • G-CSF, Neupogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response to treatment
Time Frame: Until disease progression
Until disease progression
Toxicity of treatment
Time Frame: Until completion of treatment
Until completion of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to progression
Time Frame: Until disease progression occurs
Until disease progression occurs
Over all survival
Time Frame: Until study is closed
Until study is closed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Julie R. Gralow, M.D., University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1997

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

December 6, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-5372-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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