Breast NeoplasmPhase 2NCT00194740
Taxotere Plus Weekly Navelbine and G-CSF: A Study in Stage IV Breast Cancer
A Phase 2 study testing Docetaxel, Vinorelbine and Filgrastim in people with Breast Neoplasm, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Docetaxel, Vinorelbine and Filgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)..
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Neoplasm
- Being tested
- Docetaxel, Vinorelbine, Filgrastim
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
60 mg/m2, IV, day 1 of each 21 day cycle
VinorelbineDrug
Also called Navelbine
27.5 mg/m2, IV, days 8 \& 15 of each 21 day cycle
FilgrastimDrug
Also called G-CSF, Neupogen
5 µg/kg/day s.c., to be administered days 2-21 of each cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Docetaxel; Drug: Vinorelbine; Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Measured: Until disease progression
Toxicity of treatment
Measured: Until completion of treatment
Secondary outcomes (2)
Time to progression
Measured: Until disease progression occurs
Over all survival
Measured: Until study is closed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 1997
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Investigators
- Julie R. Gralow, M.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194740
- Sponsor's protocol ID
- 97-5372-A
- Status last verified
- Dec 2007
- First submitted
- 14 Sep 2005
- Last updated
- 6 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taxotere Plus Weekly Navelbine and G-CSF: A Phase II Study in Stage IV Breast Cancer
- ClinicalTrials.gov ID
- NCT00194740
- Acronym / sponsor ID
- 97-5372-A
- Conditions
- Breast Neoplasm
- Keywords
- Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Nov 1997
- Study completion
- Jun 2007 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Docetaxel, Drug: Vinorelbine, Drug: Filgrastim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelAlso: Taxotere60 mg/m2, IV, day 1 of each 21 day cycle | Drug | 1 |
| VinorelbineAlso: Navelbine27.5 mg/m2, IV, days 8 \& 15 of each 21 day cycle | Drug | 1 |
| FilgrastimAlso: G-CSF, Neupogen5 µg/kg/day s.c., to be administered days 2-21 of each cycle. | Drug | 1 |
Primary outcome
Response to treatment
Time frame: Until disease progression
Toxicity of treatment
Time frame: Until completion of treatment
2 secondary outcomes
Time to progression
Time frame: Until disease progression occurs
Over all survival
Time frame: Until study is closed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie R. Gralow, M.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Vinorelbine and Filgrastim in people with Breast Neoplasm, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: Until disease progression). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2007.