Taxotere Plus Weekly Navelbine and G-CSF: A Study in Stage IV Breast Cancer
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ClinicalTrials.gov Identifier: NCT00194740 |
Recruitment Status
:
Completed
First Posted
: September 19, 2005
Last Update Posted
: December 6, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Neoplasm | Drug: Docetaxel Drug: Vinorelbine Drug: Filgrastim | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Taxotere Plus Weekly Navelbine and G-CSF: A Phase II Study in Stage IV Breast Cancer |
Study Start Date : | November 1997 |
Actual Study Completion Date : | June 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: Docetaxel
60 mg/m2, IV, day 1 of each 21 day cycle
Other Name: Taxotere
Drug: Vinorelbine
27.5 mg/m2, IV, days 8 & 15 of each 21 day cycle
Other Name: Navelbine
Drug: Filgrastim
5 µg/kg/day s.c., to be administered days 2-21 of each cycle.
Other Name: G-CSF, Neupogen
|
- Response to treatment [ Time Frame: Until disease progression ]
- Toxicity of treatment [ Time Frame: Until completion of treatment ]
- Time to progression [ Time Frame: Until disease progression occurs ]
- Over all survival [ Time Frame: Until study is closed ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194740
United States, Washington | |
University of Washington/Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109-1023 |
Principal Investigator: | Julie R. Gralow, M.D. | University of Washington |
Responsible Party: | Julie Gralow, M.D., University of Washington |
ClinicalTrials.gov Identifier: | NCT00194740 History of Changes |
Other Study ID Numbers: |
97-5372-A |
First Posted: | September 19, 2005 Key Record Dates |
Last Update Posted: | December 6, 2007 |
Last Verified: | December 2007 |
Keywords provided by University of Washington:
Breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Vinorelbine Docetaxel |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |