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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00593827
Other study ID # CA163-132
Secondary ID USOR 06-106
Status Completed
Phase Phase 2
First received January 4, 2008
Last updated February 9, 2016
Start date May 2008
Est. completion date August 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 was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Has MBC that is measurable by RECIST or has nonmeasurable disease with serum CA27.29 (or CA15.3) = 50

- Has Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer

- Prior chemotherapy is permitted with no limit on the number of prior regimens

- Two weeks or more have elapsed since last chemotherapy or radiation treatment

- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2

- Is female, = 18 yrs of age

- Protocol defined appropriate laboratory values

- Negative pregnancy test within 7 calendar days prior to registration

- Has signed a patient informed consent

Exclusion Criteria:

- Had prior treatment with ixabepilone or other epothilones

- Has HER2+ disease

- Has a known, prior, severe (National Cancer Institute Common Terminology Criteria Adverse Events [NCI CTCAE] Grade 3-4) history of hypersensitivity reaction to a drug formulated in Cremophor ® EL (polyoxyethylated castor oil)

- Is receiving concurrent immunotherapy, hormonal therapy or radiation therapy

- Is receiving concurrent investigational therapy or has received such therapy within the past 30 days

- Has peripheral neuropathy > Grade 1

- Has evidence of central nervous system (CNS) involvement requiring radiation or steroid treatment. Participants with stable brain metastases who are off steroids at least 2 weeks are eligible

- Is pregnant or breast feeding

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Ixabepilone
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
Ixabepilone
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.

Locations

Country Name City State
United States New York Oncology Hematology, P.C. Amsterdam New York
United States Texas Cancer Center Arlington Texas
United States Texas Oncology-Central Austin Cancer Center Austin Texas
United States Mamie Mcfaddin Ward Cancer Center Texas Oncology Beaumont Texas
United States Texas Oncology Bedord Texas
United States Birmingham Hematology & Oncology Associates Llc Birmingham Alabama
United States Central Indiana Cancer Centers Carmel Indiana
United States Maryland Oncology Hematology, P.A. Columbia Maryland
United States Missouri Cancer Associates Columbia Missouri
United States Baylor Sammons Cancer Ctr Dallas Texas
United States Texas Cancer Center At Medical City Dallas Texas
United States Texas Oncology Dallas Texas
United States Texas Oncology Sammons Cancer Center Dallas Texas
United States Texas Oncology/Methodist Charlton Cancer Ctr Dallas Texas
United States Texas Cancer Center Denton Texas
United States Regional Cancer Care Durham North Carolina
United States Puget Sound Cancer Centers Edmonds Washington
United States Texas Oncology Fort Worth Texas
United States Texas Oncology Garland Texas
United States Cancer Centers Of The Carolinas Greenville South Carolina
United States Comprehensive Cancer Center Of Nevada Henderson Nevada
United States Texas Oncology Houston Texas
United States Florida Cancer Institute Hudson Florida
United States Kansas City Cancer Center, Llc Kansas City Missouri
United States Texas Oncology - Lake Vista Cancer Center Lewisville Texas
United States Longview Cancer Center Longview Texas
United States South Texas Cancer Center Mcallen Texas
United States Texas Cancer Center Of Mesquite Mesquite Texas
United States Texas Oncology, Pa Midland Texas
United States Minnesota Oncology Hematology, P.A. Minneapolis Minnesota
United States Hematology-Oncology Assoc. Of Northern Nj, Pa Morristown New Jersey
United States Southwest Cancer Care Murrieta California
United States Cancer Care & Hematology Specialists Of Chicagoland Niles Illinois
United States Ocala Oncology Center Ocala Florida
United States Cancer Centers Of Florida, P.A Ocoee Florida
United States Texas Oncology - Odessa Odessa Texas
United States Paris Regional Cancer Center Lab Paris Texas
United States Hematology Oncology Associates Phoenix Arizona
United States Raleigh Hematology Oncology Associates Raleigh North Carolina
United States Interlakes Oncology & Hematology, P.C. Rochester New York
United States Oncology & Hematology Associates Of Southwest Virginia, Inc. Salem Virginia
United States New Mexico Cancer Care Associates Santa Fe New Mexico
United States Puget Sound Cancer Centers Seattle Washington
United States Northern Arizona Hematology & Oncology Associates Sedona Arizona
United States Texas Cancer Center - Sherman Sherman Texas
United States Cancer Care Northwest Spokane Washington
United States Evergreen Hematology And Oncology Spokane Washington
United States Arch Medical Services, Inc. St. Louis Missouri
United States Texas Oncology Cancer Center - Sugar Land Sugar Land Texas
United States Hope Center Terre Haute Indiana
United States Arizona Oncology Associates D.B.A. Hematology Oncology Tucson Arizona
United States Tyler Cancer Center Tyler Texas
United States Northwest Cancer Specialists, Pc Vancouver Washington
United States Texas Oncology Cancer Care And Research Center Waco Texas
United States Deke Slayton Cancer Center Webster Texas
United States Alliance Hematology Oncology, Pa Westminster Maryland
United States Yakima Valley Memorial Hospital/North Star Lodge Yakima Washington

Sponsors (2)

Lead Sponsor Collaborator
R-Pharm US Oncology Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Participants With Death as Outcome, Treatment-related (TR) Deaths, SAEs, TR SAEs, Adverse Events (AEs) Leading to Discontinuation, AEs, TR AEs, GR 3-4 AEs, TR GR 3-4 AEs, Drug-related (DR) Peripheral Neuropathy, Neutropenia, Alopecia 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. GR=Grade. Assessed from the date of first dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). Yes
Primary Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates. From the date of randomization to 6-months on study No
Secondary Median Progression Free Survival PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375. From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months) No
Secondary Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST] ORR is defined as the proportion of responders (complete response [CR] + partial response [PR] in participants with measurable disease) in that arm among all randomized participants.
CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions.
Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as =20 mm with conventional techniques (computed tomography [CT], magnetic resonance imaging [MRI], X-ray) or as =10 mm with spiral CT scan.
Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) No
Secondary Best Response as Assessed With RECIST Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control. Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months) No
Secondary Overall Survival (OS) Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm.
Survival time (months) = (End date - date of randomization + 1)/30.4375
From the date of randomization to date of death (maximum participant OS of 26.3 months) No
Secondary Time to Response Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR.
CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD.
From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months) No
Secondary Duration of Response Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD. From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months) No
Secondary Incidence of All Grades of Peripheral Neuropathy All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included. Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm). Yes
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