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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Breast Cancer

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Trial Information

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


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.


Inclusion Criteria:



Male or female patients will be eligible for inclusion in this study if they meet all of
the following criteria:

1. Has measurable metastatic and or locally unresectable breast cancer with documented
HER2 negative (-) disease

2. 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.

3. 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

4. Has had no adjuvant chemotherapy within the 6 months prior to study, but may have
received prior anthracyclines and/or taxanes as adjuvant chemotherapy

5. 3 weeks or more have elapsed since last chemotherapy treatment and any related
toxicities have resolved to investigational product has been administered and associated toxicities must have
resolved to
6. Has an ECOG Performance Status (PS) 0-2

7. Is ≥18 years of age

8. Has a life expectancy of at least 12 weeks

9. 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

10. 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.

11. 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

12. 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

13. Has signed the most recent Patient Informed Consent Form

14. 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.

Exclusion Criteria:

A patient will be excluded from this study if he or she meets any of the following
criteria:

1. Had prior treatment with ixabepilone or other epothilones

2. Had prior radiation to ≥30% of major bone marrow containing areas (pelvis, lumbar
spine)

3. Has ER+ and/or PR+ disease that has not progressed on hormone therapy, unless the
patient has life-threatening or rapidly progressing visceral disease

4. 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)

5. Has only lytic bone disease or nonmeasurable disease only

6. 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

7. Has been treated previously with a platinum-containing agent

8. Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy.
Washout periods for these prior therapies are specified in Section 5.

9. Is receiving concurrent investigational therapy or has received such therapy within
the 30 days prior to dosing Day 1

10. Has neuropathy (motor or sensory) >Grade 1

11. 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.

12. Has a serious uncontrolled intercurrent medical or psychiatric illness, including
serious infection

13. 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.

14. 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

15. Is a pregnant or breast feeding woman

16. Is unable to comply with the requirements of the study

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Cynthia R Osborne, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology

Authority:

United States: Institutional Review Board

Study ID:

08007

NCT ID:

NCT01075100

Start Date:

January 2010

Completion Date:

January 2014

Related Keywords:

  • Metastatic Breast Cancer
  • metastatic
  • breast
  • cancer
  • Breast Neoplasms

Name

Location

Virginia Oncology AssociatesNewport News, Virginia  23606
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
Rocky Mountain Cancer CentersThornton, Colorado  80260
Southwest Cancer CarePoway, California  92064
Cancer Care NorthwestSpokane, Washington  99202
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
Texas OncologyDallas, Texas  
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Minnesota Oncology Hematology, P.A.Minneapolis, Minnesota  55407
Medical Oncology Associates of Wyoming Valley, PCKingston, Pennsylvania  18704
Highline Medical OncologyBurien, Washington  98166
Hematology Oncology AssociatesPhoenix, Arizona  85012
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Puget Sound Cancer CentersEdmonds, Washington  98026
Paris Regional Cancer CenterParis, Texas  75460
Texas Cancer Center - ShermanSherman, Texas  75090-0504
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Melbourne Internal Medicine AssociatesMelbourne, Florida  32901
Ruth Oratz MDNew York, New York  10016
Florida Cancer Institute - New HopeNew Port Richey, Florida  34655
Northwest Cancer Specialists, PCPortland, Oregon  97225
Cancer Care Centers of South Texas-HOASTSan Antonio, Texas  78229
Texas Oncology - AmarilloAmarillo, Texas  79106
Kansas City Cancer Center, LLCKansas City, Missouri  64131
Evergreen Hematology & OncologySpokane, Washington  99218
Columbia Basin Hematology & OncologyKennewicke, Washington  99336
Texas Oncology-TylerTyler, Texas  75702
Texas Oncology - BedfordBedford, Texas  76022
Arizona Oncology Associates, PC - NAHOASedona, Arizona  86336
Arizona Oncology Associates, PC - HOPETucson, Arizona  85704
Florida Institute of Research, Medicine & SurgeryOcoee, Florida  34761
Alliance Hematology Oncology, P.A.Westminster, Maryland  21157
Maryland Oncology Hematology, PA The Medical Pavillion at Howard CountyColumbia, Missouri  21044
Comprehensive Cancer Care Centers of NevadaHenderson, Nevada  89074
Hematology-Oncology Associates of Northern NJ, PA Carol G. Simon Cancer CenterMorristown, New Jersey  07962
Interlakes Oncology & Hematology, P.CRochester, New York  14623
Dayton Oncology & Hematology, P.A. Greater Dayton Cancer CenterKettering, Ohio  45409
Texas Oncology - AbileneAbilene, Texas  79606
Texas Oncology - Austin MidtownAustin, Texas  78705
Texas Oncology Medical City DallasDallas, Texas  75230
Texas Oncology-Methodist Charlton Cancer CenterDallas, Texas  75237
Texas Oncology-Dallas Presbyterian HospitalDallas, Texas  75231
Texas Oncology- Denton SouthDenton, Texas  76210
Texas Oncology-Fort Worth 12 AveFort Worth, Texas  76104
Texas Oncology-Memorial CityHouston, Texas  77024
Texas Oncology- LewisvilleLewisville, Texas  75067
Texas Oncology-Longview Cancer CenterLongview, Texas  75601
Texas Oncology-McAllen South Second StreetMcAllen, Texas  78509
Texas Oncology-MesquiteMesquite, Texas  75150
Texas Oncology-Midland Allison Cancer CenterMidland, Texas  79701
Texas Oncology- Odessa West Texas Cancer CenterOdessa, Texas  79761
Texas Oncology - Sugar LandSugar Land, Texas  77479
Texas Oncology-WacoWaco, Texas  76712
Texas Oncology Wichita Falls Texoma Cancer CenterWichita Falls, Texas  76310
Raleigh Regional Cancer Center dba Beckley Oncology Associates Inc.Beckley, West Virginia  25801