Breast CancerPhase 2NCT00403130
Phase 2 Study of Gemzar, Taxol & Avastin Combination as 1st Line Treatment for Metastatic Breast Cancer
A Phase 2 study testing Gemcitabine, Paclitaxel and Bevacizumab in people with Breast Cancer and Metastatic Breast Cancer, run by George Albert Fisher at 1 site in United States.
Trial summary
Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Gemcitabine, Paclitaxel and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously-untreated metastatic breast cancer. May have had prior chest wall irradiation or palliative radiation to bony sites for control of pain or fracture. These sites of disease, however, will not be considered as sites of measurable disease.
- Use of bisphosphonates will be permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Granulocyte count ≥ 1500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.0 g/dL.
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- Serum glutamic oxaloacetic transaminase (SGOT) / serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 x the institutional upper limit of normal (ULN) if alkaline phosphatase is ≤ ULN or alkaline phosphatase may be up to 4 x ULN if transaminases are ≤ ULN.
- Total bilirubin within institutional limits of normal.
- Calculated creatinine clearance ≥ 30 mL/min using the formula: Ccr(mL/min) = [(140-age in years) X (wt in kg) X 0.85 (females)]/(72 x serum creatinine in mg/dL)
- ≥ 18 years of age.
- Prior anthracycline treatment in the adjuvant setting or prior chest wall radiation must have left ventricular ejection fraction (LVEF) within the institutional range of normal as assessed by pre-treatment multigated acquisition (MUGA) scan or echocardiogram (ECHO).
- All patients must give signed written informed consent.
- May have received adjuvant therapy as long as therapy complete > 12 months from study entry.
- Females of childbearing potential must have a negative pregnancy test taken ≤ 2 weeks prior to study enrollment, and must consent to the use of effective contraception during the study period and for 6months thereafter.
Who cannot join
- Receiving hormonal therapy
- Prior treatment for metastatic disease with cytotoxic agents or inhibitors of epidermal growth factor receptor (EGFR)
- Her2NEU-positive breast cancers, by either immunohistochemistry (IHC) score 3+ or fluorescence in situ hybridization (FISH)
- Pregnant or lactating.
- Patients have had active malignancies other than breast cancer in the past 5 years with the exception of in situ carcinoma of the cervix or nonmelanomatous skin cancer.
- Active or unresolved infection.
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- Pre-existing peripheral neuropathy > Grade 1.
- Prior history of severe hypersensitivity reaction to paclitaxel, gemcitabine, bevacizumab or drugs formulated with polysorbate 80.
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- Blood pressure of >150/100 mmHg
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically-significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
- Urine protein:creatinine ratio ≥ 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer
Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
Read the detailed description
This study will evaluate the time-to-progression (TTP) in patients with metastatic breast cancer, receiving 1st line therapy with bevacizumab in combination with paclitaxel and gemcitabine.
Secondary objectives will include response rates and overall survival (OS).
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- Gemcitabine, Paclitaxel, Bevacizumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Gemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
PaclitaxelDrug
Also called Taxol
Paclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles
BevacizumabDrug
Also called Avastin
Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Phase II 3-drug regimen | Experimental | Gemcitabine + Paclitaxel + Bevacizumab Receives: Drug: Gemcitabine; Drug: Paclitaxel; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Progression (TTP)
Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)
Measured: 2 years
Secondary outcomes (3)
Response Rates
The best overall response was recorded for each participant from randomization until disease progression/recurrence, using any increase from the smallest measurements recorded since randomization as the indicator of Progressive Disease (PD).
Overall response was determined on the basis of response at the target and non-target lesions, and the appearance of new lesions, as follows.
Target Nontarget New Lesions Overall Response
- Complete Complete None Overall Complete Response
- Complete Incomplete response/ None Overall Partial Response Stable Disease (SD)
- Partial Not PD None Overall Partial Response
- SD Not PD None Overall Stable Disease
- PD Any Yes/No Overall PD
- Any PD Yes/No Overall PD
- Any Any Yes Overall PD
Overall Response Rate (ORR) was assessed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.
Measured: 24 weeks
Overall Survival (OS), Confirmed
Overall Survival (OS) as determined by confirmed date of death. Participants without documentation as either alive or deceased as of 6 years from the start of treatment were considered lost-to-follow-up.
Measured: 6 years
Overall Survival (OS), All Participants
Overall Survival (OS), based on date of death or last known date alive
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2010
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Albert Fisher
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Eli Lilly and Company
- Responsible party
- Sponsor-investigator, George Albert Fisher, Stanford University
- Investigators
- George A Fisher, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403130
- Sponsor's protocol ID
- IRB-13761
- Other IDs
- 96052, BRSMTS0007
- Status last verified
- Jan 2019
- First submitted
- 22 Nov 2006
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Guardino A, et al. "Phase II Trial with Gemcitabine, Paclitaxel and Bevacizumab for the First Line Treatment of Metastatic Breast Cancer." Cancer Res. 2009;69(24_suppl)abs6089.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00403130
- Acronym / sponsor ID
- IRB-13761
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- George Albert FisherUniversity, hospital or other
- Collaborators
- Genentech, Inc., Eli Lilly and Company
- Study start
- Feb 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-institution phase 2 trial investigating the efficacy of capecitabine, oxaliplatin and bevacizumab for patients with metastatic neuroendocrine tumors.
Detailed description
This study will evaluate the time-to-progression (TTP) in patients with metastatic breast cancer, receiving 1st line therapy with bevacizumab in combination with paclitaxel and gemcitabine.
Secondary objectives will include response rates and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase II 3-drug regimen | Experimental | Drug: Gemcitabine, Drug: Paclitaxel, Drug: BevacizumabGemcitabine + Paclitaxel + Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Previously-untreated metastatic breast cancer. May have had prior chest wall irradiation or palliative radiation to bony sites for control of pain or fracture. These sites of disease, however, will not be considered as sites of measurable disease.
- Use of bisphosphonates will be permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Granulocyte count ≥ 1500/mm³
- Platelet count ≥ 100,000/mm³
Key exclusion criteria (23 listed)
- Receiving hormonal therapy
- Prior treatment for metastatic disease with cytotoxic agents or inhibitors of epidermal growth factor receptor (EGFR)
- Her2NEU-positive breast cancers, by either immunohistochemistry (IHC) score 3+ or fluorescence in situ hybridization (FISH)
- Pregnant or lactating.
- Patients have had active malignancies other than breast cancer in the past 5 years with the exception of in situ carcinoma of the cervix or nonmelanomatous skin cancer.
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 |
|---|---|---|
| GemcitabineAlso: GemzarGemcitabine 1000 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles | Drug | Phase II 3-drug regimen |
| PaclitaxelAlso: TaxolPaclitaxel 80 mg/m2 by IV infusion, days 1, 8, and 15 in 28-day cycles | Drug | Phase II 3-drug regimen |
| BevacizumabAlso: AvastinBevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles | Drug | Phase II 3-drug regimen |
Primary outcome
Time-to-Progression (TTP)
Time frame: 2 years
Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)
3 secondary outcomes
Response Rates
Time frame: 24 weeks
Overall Survival (OS), Confirmed
Time frame: 6 years
Overall Survival (OS), All Participants
Time frame: 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGuardino A, et al. "Phase II Trial with Gemcitabine, Paclitaxel and Bevacizumab for the First Line Treatment of Metastatic Breast Cancer." Cancer Res. 2009;69(24_suppl)abs6089.
- Individual participant dataSharing planned: No
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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.
George A Fisher, MD, PhD principal investigator
Stanford University
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 Gemcitabine, Paclitaxel and Bevacizumab in people with Breast Cancer and Metastatic Breast Cancer, run by George Albert Fisher 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 14 inclusion and 23 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 20 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time-to-Progression (TTP) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00403130, which also lists 1 linked publication.
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 20 Feb 2019.