Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

— IXTEND  

Official title:

IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00546364
• Other study ID #: CA163-131
• Status: Terminated
• Phase: Phase 2
• First received: October 17, 2007
• Last updated: February 9, 2016
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2016
• Source: R-Pharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of ixabepilone plus capecitabine or docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in women. The safety of this combination therapy will also be evaluated.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with metastatic breast cancer

• Measurable disease

• Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel was received 12 months or less before the treatment. There is no timeframe for prior paclitaxel in the metastatic setting.

• Human epidermal growth factor receptor 2-positive participants allowed if they have progressed after receiving treatment with trastuzumab or lapatinib

• Eastern Cooperative Oncology Group Performance status of 0-1

• Age younger than 18 years

• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of investigational products

Exclusion Criteria:

• More than 1 chemotherapy regimen for the treatment of metastatic breast cancer

• Prior treatment with any epothilone, capecitabine, or docetaxel

• Prior radiation must not have included 30% or more of major bone marrow-containing areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval of 2 weeks must be allowed between the last radiation treatment and administration of study medication. There must be at least 1 week between focal/palliative radiation and administration of study medication.

• Any current or previous history of brain and/or leptomeningeal metastases

• Neuropathy greater than Grade 2

• Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix

• Uncontrolled diabetes mellitus

• Chronic hepatitis

• HIV-positive status

• Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for cancer must be discontinued 28 days prior to study medication. Hormonal anticancer agents must be discontinued at least 14 days prior to study medication. Hormonal replacement therapy is acceptable

• Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days before study entry

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
• Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2
Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
• Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.

Locations

Country	Name	City	State
United States	Akron General Medical Center	Akron	Ohio
United States	Summa Health System	Akron	Ohio
United States	UNM Cancer Center	Albuquerque	New Mexico
United States	Medical Oncology Associates of Augusta, PC	Augusta	Georgia
United States	Austin Cancer Centers	Austin	Texas
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Hematology/Oncology Clinic	Baton Rouge	Louisiana
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Center for Cancer & Blood Disorders, PC	Bethesda	Maryland
United States	Local Institution	Canton	Ohio
United States	Charleston Cancer Center	Charleston	South Carolina
United States	The Center for Cancer and Hematologic Disease	Cherry Hill	New Jersey
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Mid Ohio Oncology/Hematology, Inc, dba The Mark H Zangmeister Center	Columbus	Ohio
United States	Cancer Specialists of South Texas	Corpus Christi	Texas
United States	Coastal Bend Cancer Center	Corpus Christi	Texas
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Edward L Middleman, MD	Duncanville	Texas
United States	Hematology & Oncology Associates of Nepa	Dunmore	Pennsylvania
United States	Gaston Hematology and Oncology	Gastonia	North Carolina
United States	Center for Cancer Care at Goshen Health System	Goshen	Indiana
United States	The Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Local Institution	Honolulu	Hawaii
United States	Section Chief Medical Oncology	Houston	Texas
United States	Howell Office Plaza	Howell	New Jersey
United States	Jackson Oncology Associates, Pllc	Jackson	Mississippi
United States	Local Institution	Jacksonville	Florida
United States	Kingsport Hematology Oncology	Kingsport	Tennessee
United States	The University of Tennessee Medical Center	Knoxville	Tennessee
United States	Leah L Dietrich, MD	La Crosse	Wisconsin
United States	Scripps Cancer Center	La Jolla	California
United States	Arena Oncology Associates, PC	Lake Success	New York
United States	Regional Hematology Oncology, PC	Langhorne	Pennsylvania
United States	St Mary Medical Center	Langhorne	Pennsylvania
United States	University of Kentucky	Lexington	Kentucky
United States	University Medical Center, Inc	Louisville	Kentucky
United States	Jose A Figueroa, MD	Lubbock	Texas
United States	Local Institution	Miami	Florida
United States	Lowcountry Hematology & Oncology, PA	Mt Pleasant	South Carolina
United States	Monroe Medical Associates	Munster	Indiana
United States	Local Institution	Newark	Delaware
United States	Local Institution	Newark	New Jersey
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Hematology Oncology Associates of Rockland	Nyack	New York
United States	John W Kugler, MD	Peoria	Illinois
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Local Institution	Philadelphia	Pennsylvania
United States	New Mexico Cancer Care Associates (NMCCA)	Santa Fe	New Mexico
United States	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota
United States	Cancer Center of Central Connecticut	Southington	Connecticut
United States	Southlake Oncology	Southlake	Texas
United States	Providence Cancer Center	Spokane	Washington
United States	Santee Hematology/Oncology	Sumter	South Carolina
United States	Dch Cancer Treatment Center	Tuscaloosa	Alabama
United States	Cooper Hospital, Division of Hematology/Oncology	Voorhees	New Jersey
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Marion L Shepard Cancer Center	Washington	North Carolina
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Local Institution	Woonsocket	Rhode Island
United States	Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
R-Pharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)	RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.	Baseline to 6 weeks (end of Cycle 2)	No
Primary	Percentage of Participants With Best Response to Treatment of Complete or Partial	The tumor response rate is defined as the number of participants with a best tumor response of CR or PR (as assessed by the investigator according to RECIST criteria), divided by the number of participants randomized in that arm.	Baseline to 6 weeks (end of Cycle 2)	No
Secondary	Percentage of Triple-negative (TN) Participants With Best Response to Treatment of Complete or Partial	The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not over express human epidermal growth factor receptor 2 (HER2).	Baseline to 6 weeks (end of Cycle 2)	No
Secondary	Percentage of Nontriple-negative (NTN) Participants With Best Response to Treatment of Complete or Partial Per Cohort	The tumor response rate is defined as the total number of participants whose best response is CR or PR, divided by the number of randomized participants. Participants not evaluable for response are considered to be nonresponders. NTN participants are who are not TN participants (TN participants are those with tumors that do not express estrogen or progesterone receptors and that do not overexpress HER2) and who received ixabepilone plus capecitabine or docetaxel plus capecitabine.	Baseline to 6 weeks (end of Cycle 2)	No
Secondary	Number of Participants With Death, Adverse Events (AEs), Drug-related AEs, Serious AEs (SAEs), Drug-related SAEs, AEs Leading to Discontinuation (AEDs), Drug-related AEDs, and Drug-related Peripheral Neuropathy	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, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related or of unknown relationship to study treatment. Grade 3=Severe, Grade 4=Life-threatening.	Baseline to end of Cycle 1 (21 days), continuously	Yes
Secondary	Number of Participants With Abnormalities in Hematology Laboratory Results by Worst Common Terminology Criteria (CTC) Grade	CTC Grade 1=Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2=Moderate; minimal, local or noninvasive intervention indicated. Grade 3=Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4=Life-threatening consequences; urgent intervention indicated.	Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle	Yes
Secondary	Number of Participants With Abnormalities in Serum Chemistry Laboratory Results	ULN=Upper limit of normal among all laboratory ranges. Alanine aminotransferase (ALT) Grade 1:>ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Aspartate aminotransferase (AST) Grade 1: >ULN to 2.5*ULN; Grade 2: >2.5 to 5.0*ULN; Grade 3: >5.0 to 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN to 1.5*ULN; Grade 2: >1.5 to 3.0*ULN; Grade 3: >3.0 to 10.0*ULN; Grade 4: >10.0*ULN. Creatine Grade 1: >ULN to 1.5*ULN; Grade 2: 1.5 to 3.0*ULN; Grade 3: >3.0 to 6.0*ULN; Grade 4: >6.0*ULN.	Baseline in Cycle 1 (21 days) and then prior to start of each 21-day cycle	Yes
Secondary	Time to Progression	Time to progression is defined as the time from date of randomization until the date that PD is first reported. Participants who die without a reported prior progression are considered to have progressed on the day of their death. Those who did not progress or die are censored at the day of their last tumor assessment.	Baseline to date progressive disease reported	No
Secondary	Duration of Response	Duration of overall response is computed for participants whose best response is either PR or CR and is measured from the time measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of documented PD or death. Participants who did not relapse or die are censored on the date of their last tumor assessment.	Baseline (date of randomization) to date CR or PR criteria first met	Yes
Secondary	Median Number of Treatment Cycles	The first dosing date is defined as the date of the first dose of chemotherapy or capecitabine, whichever was administered first. Cycles are defined as the time from Day 1 of the cycle until the day before the next cycle. The last cycle per participant is the 21-day period following Day 1 of that cycle.	Day 1 to end of Cycle 18, maximum (54 weeks)	No

External Links

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