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Metastatic Breast CancerPhase 2NCT01075100

Ixabepilone + Carboplatin Metastatic Breast Cancer

A Phase 2 study testing Ixabepilone and Carboplatin in people with Metastatic Breast Cancer, run by US Oncology Research at 59 sites in United States.

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

Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. 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 and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
59 sitesUnited States
Study dates
Jan 2010to Jun 2013
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

  • Male or female patients will be eligible for inclusion in this study if they meet all of the following criteria:
  • Has measurable metastatic and or locally unresectable breast cancer with documented HER2 negative (-) disease
  • Has at least 1 measurable lesion per RECIST criteria (lesions that can be accurately measured in at least 1 dimension (longest diameter (LD) to be recorded) as ≥20 mm with conventional techniques (CT, MRI, X-ray) or as ≥10 mm with spiral CT scan). Irradiated lesions cannot be used to assess response but can be used to assess progression.
  • Has received up to 2 (0 to 2) prior chemotherapy regimens for metastatic disease with the following conditions:
  • •Has had no prior treatment with ixabepilone or platinum agents
  • Has had no adjuvant chemotherapy within the 6 months prior to study, but may have received prior anthracyclines and/or taxanes as adjuvant chemotherapy
Show all 17Show fewer
  • 3 weeks or more have elapsed since last chemotherapy treatment and any related toxicities have resolved to <Grade 1; at least 30 days must have passed since any investigational product has been administered and associated toxicities must have resolved to <Grade 1 (if applicable).
  • Has an ECOG Performance Status (PS) 0-2
  • Is ≥18 years of age
  • Has a life expectancy of at least 12 weeks
  • Has laboratory values of:
  • White blood cell (WBC) count ≥3000 x 106/L Absolute neutrophil count (ANC) ≥1500 x 106/L Hemoglobin ≥9 g/dL Total bilirubin ≤1x upper limit of normal (ULN) AST and ALT ≤2.5 x ULN Alkaline phosphatase ≤2.5 x ULN; up to 5xULN if elevation is due to bone disease Serum creatinine ≤1.5 mg/dL Calculated creatinine clearance >50 mL/min (based on Cockroft and Gault method [Appendix III]) Platelet count ≥100,000 x 106/L
  • If patient has had radiation therapy, it has been completed >3 weeks prior to the start of study treatment. NOTE: Previously irradiated lesions will not be evaluable. However, these patients will still be eligible.
  • Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause
  • If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
  • Has signed the most recent Patient Informed Consent Form
  • Has signed a Patient Authorization Form Note: Having tissue available is not an inclusion criterion in this study; however, available tissue will be collected (see Section 8) if possible.

Who cannot join

  • A patient will be excluded from this study if he or she meets any of the following criteria:
  • Had prior treatment with ixabepilone or other epothilones
  • Had prior radiation to ≥30% of major bone marrow containing areas (pelvis, lumbar spine)
  • Has ER+ and/or PR+ disease that has not progressed on hormone therapy, unless the patient has life-threatening or rapidly progressing visceral disease
  • Has HER2+ disease (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells]), a FISH result of more than 6 HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals of >2.2)
  • Has only lytic bone disease or nonmeasurable disease only
Show all 17Show fewer
  • Has a known, prior, severe (NCI CTCAE Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor®EL (polyoxyethylated castor oil) or has history of severe allergic reactions to cisplatin or other platinum-containing compounds
  • Has been treated previously with a platinum-containing agent
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Washout periods for these prior therapies are specified in Section 5.
  • Is receiving concurrent investigational therapy or has received such therapy within the 30 days prior to dosing Day 1
  • Has neuropathy (motor or sensory) >Grade 1
  • Has evidence of CNS involvement requiring radiation or steroid treatment. Patients with stable brain metastases who are off steroids at least 2 weeks are eligible.
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
  • Has clinically relevant coagulopathy either secondary to hepatic dysfunction or an underlying condition requiring therapeutic anticoagulation (specifically, A-fib, history of DVT). A daily aspirin or Plavix for CAD are permitted.
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
  • Is a pregnant or breast feeding woman
  • Is unable to comply with the requirements of the study

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Texas Oncology - Abilene

    Abilene, Texas, 79606

  • Texas Oncology - Amarillo

    Amarillo, Texas, 79106

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Raleigh Regional Cancer Center dba Beckley Oncology Associates Inc.

    Beckley, West Virginia, 25801

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Highline Medical Oncology

    Burien, Washington, 98166

  • Central Indiana Cancer Centers

    Carmel, Indiana, 46032

  • Maryland Oncology Hematology, PA The Medical Pavillion at Howard County

    Columbia, Missouri, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Oncology Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology-Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Methodist Charlton Cancer Center

    Dallas, Texas, 75237

  • Texas Oncology

    Dallas, Texas, 75246

  • Texas Oncology- Denton South

    Denton, Texas, 76210

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Puget Sound Cancer Centers

    Edmonds, Washington, 98026

  • Texas Oncology-Fort Worth 12 Ave

    Fort Worth, Texas, 76104

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Comprehensive Cancer Care Centers of Nevada

    Henderson, Nevada, 89074

  • Texas Oncology-Memorial City

    Houston, Texas, 77024

  • Florida Cancer Institute - New Hope

    Hudson, Florida, 34667

  • Kansas City Cancer Center, LLC

    Kansas City, Missouri, 64131

  • Columbia Basin Hematology & Oncology

    Kennewick, Washington, 99336

  • Dayton Oncology & Hematology, P.A. Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • Texas Oncology- Lewisville

    Lewisville, Texas, 75067

  • Texas Oncology-Longview Cancer Center

    Longview, Texas, 75601

  • Texas Oncology-McAllen South Second Street

    McAllen, Texas, 78509

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Texas Oncology-Mesquite

    Mesquite, Texas, 75150

  • Texas Oncology-Midland Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • Hematology-Oncology Associates of Northern NJ, PA Carol G. Simon Cancer Center

    Morristown, New Jersey, 07962

  • Southwest Cancer care

    Murrieta, California, 92562

  • Ruth Oratz MD

    New York, New York, 10016

  • Cancer Care & Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Florida Institute of Research, Medicine & Surgery

    Ocoee, Florida, 34761

  • Texas Oncology- Odessa West Texas Cancer Center

    Odessa, Texas, 79761

  • Paris Regional Cancer Center

    Paris, Texas, 75460

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Northwest Cancer Specialists, PC

    Portland, Oregon, 97213

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27607

  • Interlakes Oncology & Hematology, P.C

    Rochester, New York, 14623

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Cancer Care Centers of South Texas

    San Antonio, Texas, 78217

  • Cancer Care Centers of South Texas-HOAST

    San Antonio, Texas, 78229

  • Puget Sound Cancer Centers

    Seattle, Washington, 98133

  • Arizona Oncology Associates, PC - NAHOA

    Sedona, Arizona, 86336

  • Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Cancer Care Northwest

    Spokane, Washington, 99202

  • Evergreen Hematology & Oncology

    Spokane, Washington, 99218

  • Texas Oncology - Sugar Land

    Sugar Land, Texas, 77479

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85704

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Texas Oncology-Waco

    Waco, Texas, 76712

  • Alliance Hematology Oncology, P.A.

    Westminster, Maryland, 21157

  • Texas Oncology Wichita Falls Texoma Cancer Center

    Wichita Falls, Texas, 76310

  • Yakima Valley Memorial Hospital/North Star Lodge

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study

Ixabepilone adds significantly to the antitumor effectiveness of capecitabine in both ER+ and triple negative breast cancer. Ixabepilone has substantial antitumor activity in taxane-refractory patients and novel combinations are needed in this poor prognosis population. Carboplatin in combination with gemcitabine or paclitaxel has activity in metastatic breast cancer (MBC); there is also demonstrated activity of the gemcitabine/carboplatin combination in the ER+ versus triple negative subsets. A Phase I study of ixabepilone plus carboplatin in solid tumor patients demonstrated the safety of this combination at the doses and schedule proposed for this Phase II trial (BMS data on file).

Read the detailed description

This is a Phase II, open label, nonrandomized, parallel, noncomparative, study of 2 groups (as stratified below). All patients will receive ixabepilone 20 mg/m2 on Days 1 and 8 and carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. Patients will be stratified by either hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]- (n=50) or triples negative ER-/PR-/HER2- (n=53). If one group fulfills their accrual goal first, registration into that strata will be stopped and only patients meeting stratification requirements for the other group will be registered.

Being tested
Ixabepilone, Carboplatin
Keywords
metastatic, breast, cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Neoplasms

What participants receive

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

  • IxabepiloneDrug

    Also called Ixempra, azaepothilone B

    20 mg/m2 on Days 1 and 8

  • CarboplatinDrug

    Also called Paraplatin

    carboplatin AUC=2.5 on Days 1 and 8

Study groups in NCT01075100
Study groupRoleWhat they receive
Weekly Ixabepilone +carboplatinExperimentalSubjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle.
Receives: Drug: Ixabepilone; Drug: Carboplatin

What is being measured

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

  1. Objective Response Rate (ORR)

    Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 24 months

Secondary outcomes (5)

  1. Clinical Benefit Rate (CBR)

    Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months

    Measured: 24 months

  2. Progression-free Survival (PFS)

    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 24 months

  3. Overall Survival (OS)

    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    Measured: 24 months

  4. Time to Response

    For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.

    Measured: 24 months

  5. Duration of Response

    The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

    Measured: 30 months

Timeline

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

  1. First posted24 Feb 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJun 2013
  4. Study completionJun 2013

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01075100
Sponsor's protocol ID
08007
Status last verified
Oct 2016
First submitted
14 Jan 2010
Last updated
7 Dec 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixabepilone and Carboplatin in people with Metastatic Breast Cancer, run by US Oncology Research at 59 sites 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 17 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites 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 7 Dec 2016). 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?

Objective Response Rate (ORR) (time frame: 24 months). 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 NCT01075100.

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 7 Dec 2016.

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