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

NCT00194740 | Completed Phase 2

• 1 other identifier: 97-5372-A
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasm

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (2)

• Response to treatment

  Until disease progression

• Toxicity of treatment

  Until completion of treatment

Secondary Outcomes (2)

• Time to progression

  Until disease progression occurs

• Over all survival

  Until study is closed

Study Arms (1)

1

EXPERIMENTAL

Drug: Docetaxel; Drug: Vinorelbine; Drug: Filgrastim

Interventions

Docetaxel DRUG

60 mg/m2, IV, day 1 of each 21 day cycle

Also known as: Taxotere

1

Vinorelbine DRUG

27.5 mg/m2, IV, days 8 \& 15 of each 21 day cycle

Also known as: Navelbine

1

Filgrastim DRUG

5 µg/kg/day s.c., to be administered days 2-21 of each cycle.

Also known as: G-CSF, Neupogen

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Vinorelbine; Filgrastim; Granulocyte Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Julie R. Gralow, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 19, 2005
• Study Start: November 1, 1997
• Study Completion: June 1, 2007
• Last Updated: December 6, 2007

Record last verified: 2007-12

Locations

US (1)