AzTrials
AzTrials

Metastatic Breast CancerPhase 2NCT00370552

A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast Cancer

A Phase 2 study testing Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg, Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg and Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg in people with Metastatic Breast Cancer, run by R-Pharm at 25 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg, Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg and Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
25 sitesin 5 countries
Study dates
Mar 2007to Nov 2009
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally recurrent or metastatic breast cancer, previously untreated with chemotherapy for advanced disease.
  • At least 1 target lesion per RECIST criteria. Locally recurrent disease must not be amenable to resection with curative intent.
  • No previous cytotoxic chemotherapy for locally recurrent/metastatic disease.
  • Relapse 12 months or more after completing prior adjuvant or neoadjuvant taxane therapy.
  • No previous breast cancer known to overexpress or amplify the human epidermal growth factor receptor 2 gene.
  • Prior hormonal therapy in adjuvant, recurrent, or metastatic setting allowed but must have been discontinued at least 2 weeks before randomization.
Show all 18Show fewer
  • Karnofsky performance status of 80 to 100 or Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Estimated life expectancy of at least 12 weeks.
  • Recovery from recent therapy (except for alopecia), including chemotherapy, immunotherapy, biologic therapy, or investigational product. Any such therapy must have been completed at least 3 weeks before randomization and at least 6 weeks from use of nitrosourea, or mitomycin.
  • Recovery from recent surgery and radiation therapy. At least 1 week since minor surgery and/or focal/palliative radiation therapy; at least 3 weeks from radiation; at least 4 weeks from major surgery; and at least 8 weeks from liver resection, thoracotomy, or neurosurgery.
  • Absolute neutrophil count ≥1500/mm^3.
  • Hemoglobin ≥9 g/dL.
  • Platelets ≥100,000/mm^3.
  • Total bilirubin ≤1.5 times the upper limit of normal (ULN).
  • Aspartate aminotransferase or alanine aminotransferase ≤2.5*ULN.
  • Normal partial thromboplastin time and either international normalized ratio or prothrombin time <1.5*ULN.
  • Serum creatinine ≤1.5*ULN or 24-hour creatinine clearance >60 mL/min.
  • Urine dipstick for proteinuria <2+ (negative, trace, or +1). Participants with ≥2+ proteinuria at baseline were to undergo 24-hour urine collection and demonstrate ≤1g of protein in 24 hours to be eligible.

Who cannot join

  • Women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 6 months after treatment with bevacizumab.
  • Women who were pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Sexually active fertile men, whose partners were WOCBP, not using an adequate method of birth control.
  • Evidence of baseline sensory or motor neuropathy.
  • Serious infection or nonmalignant medical illnesses uncontrolled or the control of which could be jeopardized by this therapy.
Show all 19Show fewer
  • History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious gastric ulcer, or bone fracture within 6 months of study entry.
  • History of hypertensive crisis or hypertensive encephalopathy.
  • Significant vascular disease.
  • Clinically significant cardiovascular disease.
  • Baseline left ventricular ejection fraction by multiple-gated acquisition scan or echocardiogram for subjects with prior exposure to anthracyclines not within institutional normal limits.
  • Symptomatic peripheral vascular disease.
  • History of high dose chemotherapy with bone marrow transplant or peripheral blood stem cell transplant within the previous 2 years.
  • Evidence of bleeding diathesis or coagulopathy.
  • Prior treatment with an epothilone or any antiangiogenic agent.
  • Concurrent nonhealing wound, ulcer, or fracture.
  • Any current or history of brain and/or leptomeningeal metastases. Psychiatric disorders or other conditions rendering the participant incapable of complying with the requirements of the protocol.
  • Any concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix.
  • Known allergy to any of the study drugs or their excipients.

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

France7 sites

  • Local Institution

    Besançon, 25030

  • Local Institution

    Clermont-Ferrand, 63000

  • Local Institution

    Marseille, 13273

  • Local Institution

    Paris, 75475

  • Local Institution

    Saint-Herblain, 44805

  • Local Institution

    Strasbourg, 67085

  • Local Institution

    Tours, 37044

Other trials in France

United States6 sites

  • East Valley Hematology And Oncology Medical Group

    Burbank, California, 91505

  • Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • Wilshire Oncology Medical Group, Inc.

    La Verne, California, 91750

  • Weill Medical College Of Cornell University

    New York, New York, 10021

  • Ucsf-Comprehensive Cancer Center

    San Francisco, California, 94115

Other trials in United States

Italy6 sites

  • Local Institution

    Cuneo, 12100

  • Local Institution

    Meldola Fc, 47014

  • Local Institution

    Milan, 20132

  • Local Institution

    Modena, 41100

  • Local Institution

    Naples, 80131

  • Local Institution

    Roma, 00161

Other trials in Italy

United Kingdom4 sites

  • Local Institution

    Chelmsford, Essex, CM1 7ET

  • Local Institution

    Manchester, Greater Manchester, M20 4BX

  • Local Institution

    Merseyside, Merseyside, CH63 4JY

  • Local Institution

    Nottingham, Nottinghamshire, NG5 1PB

Other trials in United Kingdom

Spain2 sites

  • Local Institution

    Jaén, 23007

  • Local Institution

    L'Hospitalet de Llobregat, 08907

Other trials in Spain

About this study

Official title: A Phase II Open Label, Randomized, 3 Arm Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab as First Line Therapy for Locally Recurrent or Metastatic Breast Cancer

The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.

Being tested
Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg, Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg, Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kgDrug

    Also called IXEMPRA, BMS-247550

    Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.

  • Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kgDrug

    Also called IXEMPRA, BMS-247550

    Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m^2 was to be implemented for all subsequent cycles.) Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.

  • Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kgDrug

    Also called TAXOL, BMS-181339

    Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.

Study groups in NCT00370552
Study groupRoleWhat they receive
Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kgExperimentalNot described
Receives: Drug: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg
Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kgExperimentalNot described
Receives: Drug: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg
Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kgActive comparatorNot described
Receives: Drug: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study

    CR=Disappearance of all clinical and radiologic evidence of target lesions; PR=At least 30% reduction in the sum of the longest diameter of all target lesions.

    Measured: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression

  2. Number of Participants With Best Response As Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)

    Best tumor response was assessed with RECIST. Complete response (CR)=Disappearance of all evidence of target lesions; Partial response (PR)=At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions; Progressive disease (PD)=At least a 20% increase from baseline in the sum of LD of target lesions or the appearance of 1 or more new lesions; Stable disease (SD)=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. A response was confirmed if noted on 2 examinations at least 4 weeks apart.

    Measured: Baseline visit and then every 8 weeks to 12 months, then every 3 months until disease progression

Secondary outcomes (9)

  1. Percentage of Participants With Progression-free Survival at Week 24

    Week 24 Progression-free Survival was defined as the number of participants who neither progressed nor died before Week 24. Computed using Kaplan-Meier estimates, only at the time of Interim Analysis, when all participants had been followed for 6 months.

    Measured: Date of randomization to Week 24

  2. Median Progression-free Survival (PFS)

    PFS was defined as the time from randomization to progression or to death from any cause without prior documentation of progression. Participants who did not progress or die were to be censored on the date of their last tumor assessment.

    Measured: Date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 29 months)

  3. Median Time to Response

    Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for a PR or CR, whichever was recorded first. Time to response was computed only for participants whose best response was PR or CR.

    Measured: Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant time to response of 67 weeks)

  4. Median Duration of Response

    Duration of response was computed for participants whose best response was either PR or CR. Duration of overall response was defined as the period from the time that measurement criteria were first met for PR or CR, whichever was recorded first, until the first date of documented PD or death. Participants who neither relapsed nor died were to be censored on the date of their last tumor assessment.

    Measured: Date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 25 weeks)

  5. Percentage of Participants Surviving at 1 Year

    One year survival rates were computed using Kaplan-Meier estimates.

    Measured: Date first participant enrolled to 1 year

  6. Number of Participants With Death as Outcome, Serious Adverse Events (SAEs) Treatment-related SAEs, Treatment-related Adverse Events (AEs) Leading to Discontinuation, AEs Leading to Discontinuation, Treatment-related AEs

    An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency or abuse; is life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment related=possibly, probably, or certainly related to and of unknown relationship to study treatment.

    Measured: At initiation of treatment throughout study, to a minimum of 30 days after last dose of study drug

  7. Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade

    CTC, Version 3 used to assess parameters. CTC Gr=Grade; WBC=white blood cells; ANC=absolute neutrophil count. LLN=lower level of normal. WBC Gr 1:<LLN to 3.0*10^9/L, Gr 2:<3.0 to 2.0*10^9/L, Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L; ANC Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L; Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L; Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL.

    Measured: At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle

  8. Number of Participants With Abnormalities in Liver Function by Worst CTC Grade

    ULN=Upper limit of normal.ALT Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; AST Gr 1: >ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; ALP Gr 1:>ULN to 2.5*ULN, Gr 2: >2.5 to 5.0*ULN, Gr 3: >5.0 to 20.0*ULN, Gr 4: >20.0*ULN; Total bilirubin Gr 1: >ULN to 1.5*ULN, Gr 2: >1.5 to 3.0*ULN, Gr 3: >3.0 to 10.0*ULN, Gr 4: >10.0*ULN.

    Measured: At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle

  9. Number of Participants With Abnormalities in Renal Function by Worst CTC Grade

    Creatine Gr 1: >ULN to 1.5*ULN, Gr 2: 1.5 to 3.0*ULN, Gr 3: >3.0 to 6.0*ULN, Gr 4: >6.0*ULN.

    Measured: At initiation of treatment and throughout study, to a minimum of 30 days after last dose of study drug. Laboratory tests performed within 72 hours before start of each cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2006 (estimated)
  2. Study startMar 2007
  3. Primary completionNov 2009
  4. Study completionNov 2009

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00370552
Sponsor's protocol ID
CA163-115
Status last verified
Feb 2016
First submitted
30 Aug 2006
Last updated
10 Mar 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg, Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg and Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg in people with Metastatic Breast Cancer, run by R-Pharm at 25 sites in 5 countries.

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 18 inclusion and 19 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 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France, United States, Italy, United Kingdom, Spain. 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 14 Apr 2011). 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?

Percentage of Participants With Best Tumor Response of Partial Response (PR) or Complete Response (CR) While On-study (time frame: Baseline visit and then every 8 weeks to 12 months, then every 3 months 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?

On the ClinicalTrials.gov record for NCT00370552.

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 10 Mar 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT00370552 | AzTrials