Ixabepilone + Carboplatin Metastatic Breast Cancer

NCT01075100 | Completed Phase 2 Results DMC

• 1 other identifier: 08007
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 59

Brief 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. 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).

Conditions

Metastatic Breast Cancer

Keywords

metastatic; breast; cancer

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (5)

• Clinical Benefit Rate (CBR)

  24 months

• Progression-free Survival (PFS)

  24 months

• Overall Survival (OS)

  24 months

• Time to Response

  24 months

• Duration of Response

  30 months

Study Arms (1)

Weekly Ixabepilone +carboplatin

EXPERIMENTAL

Subjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle.

Drug: Ixabepilone; Drug: Carboplatin

Interventions

Ixabepilone DRUG

20 mg/m2 on Days 1 and 8

Also known as: Ixempra, azaepothilone B

Weekly Ixabepilone +carboplatin

Carboplatin DRUG

carboplatin AUC=2.5 on Days 1 and 8

Also known as: Paraplatin

Weekly Ixabepilone +carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Bristol-Myers Squibb: collaborator

Study Sites (59)

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Arizona Oncology Associates, PC - NAHOA

Sedona, Arizona, 86336, United States

Location

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, 85704, United States

Location

Southwest Cancer care

Murrieta, California, 92562, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80220, United States

Location

Florida Cancer Institute - New Hope

Hudson, Florida, 34667, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Florida Institute of Research, Medicine & Surgery

Ocoee, Florida, 34761, United States

Location

Cancer Care & Hematology Specialists of Chicagoland

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Centers

Carmel, Indiana, 46032, United States

Location

Alliance Hematology Oncology, P.A.

Westminster, Maryland, 21157, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Maryland Oncology Hematology, PA The Medical Pavillion at Howard County

Columbia, Missouri, 21044, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Kansas City Cancer Center, LLC

Kansas City, Missouri, 64131, United States

Location

St. Joseph Oncology, Inc.

Saint Joseph, Missouri, 64507, United States

Location

Comprehensive Cancer Care Centers of Nevada

Henderson, Nevada, 89074, United States

Location

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

Morristown, New Jersey, 07962, United States

Location

Ruth Oratz MD

New York, New York, 10016, United States

Location

Interlakes Oncology & Hematology, P.C

Rochester, New York, 14623, United States

Location

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, 27607, United States

Location

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

Kettering, Ohio, 45409, United States

Location

Northwest Cancer Specialists, PC

Portland, Oregon, 97213, United States

Location

Medical Oncology Associates of Wyoming Valley, PC

Kingston, Pennsylvania, 18704, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Texas Oncology - Abilene

Abilene, Texas, 79606, United States

Location

Texas Oncology - Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Oncology - Austin Midtown

Austin, Texas, 78705, United States

Location

Texas Oncology - Bedford

Bedford, Texas, 76022, United States

Location

Texas Oncology Medical City Dallas

Dallas, Texas, 75230, United States

Location

Texas Oncology-Dallas Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

Texas Oncology-Methodist Charlton Cancer Center

Dallas, Texas, 75237, United States

Location

Texas Oncology

Dallas, Texas, 75246, United States

Location

Texas Oncology- Denton South

Denton, Texas, 76210, United States

Location

Texas Oncology-Fort Worth 12 Ave

Fort Worth, Texas, 76104, United States

Location

Texas Oncology-Memorial City

Houston, Texas, 77024, United States

Location

Texas Oncology- Lewisville

Lewisville, Texas, 75067, United States

Location

Texas Oncology-Longview Cancer Center

Longview, Texas, 75601, United States

Location

Texas Oncology-McAllen South Second Street

McAllen, Texas, 78509, United States

Location

Texas Oncology-Mesquite

Mesquite, Texas, 75150, United States

Location

Texas Oncology-Midland Allison Cancer Center

Midland, Texas, 79701, United States

Location

Texas Oncology- Odessa West Texas Cancer Center

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78217, United States

Location

Cancer Care Centers of South Texas-HOAST

San Antonio, Texas, 78229, United States

Location

Texas Cancer Center - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology - Sugar Land

Sugar Land, Texas, 77479, United States

Location

Texas Oncology-Tyler

Tyler, Texas, 75702, United States

Location

Texas Oncology-Waco

Waco, Texas, 76712, United States

Location

Texas Oncology Wichita Falls Texoma Cancer Center

Wichita Falls, Texas, 76310, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Highline Medical Oncology

Burien, Washington, 98166, United States

Location

Puget Sound Cancer Centers

Edmonds, Washington, 98026, United States

Location

Columbia Basin Hematology & Oncology

Kennewick, Washington, 99336, United States

Location

Puget Sound Cancer Centers

Seattle, Washington, 98133, United States

Location

Cancer Care Northwest

Spokane, Washington, 99202, United States

Location

Evergreen Hematology & Oncology

Spokane, Washington, 99218, United States

Location

Yakima Valley Memorial Hospital/North Star Lodge

Yakima, Washington, 98902, United States

Location

Raleigh Regional Cancer Center dba Beckley Oncology Associates Inc.

Beckley, West Virginia, 25801, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Neoplasms

Interventions

ixabepilone; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. Cynthia Osborne
• Organization: US Oncology Research, McKesson Specialty Health

Cynthia.Osborne@usoncology.com

214-370-1057

Study Officials

• Cynthia R Osborne, MD

  US Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: February 24, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 7, 2016
• Results First Posted: December 7, 2016

Record last verified: 2016-10

Locations

US (59)