- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463072
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Efficacy and Tolerability of Nanoparticle Albumin Bound Paclitaxel (Abraxane) in Patients 65 and Older With Locally Advanced or Metastatic Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the tolerability (grade 2-5 toxicity, neuropathy grade 2 or higher, need for dose reductions, or delays) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy (response and time to progression) of weekly nab-paclitaxel in older adults with locally advanced or metastatic breast cancer using a stratification factor based on patient age (at least 5 patients age 75 years or older and no more than 15 patients age 65-70 years).
II. To explore predictors of the need for dose reduction, dose delays, or grade 2-5 toxicity and neuropathy grade 2 or higher based on a cancer-specific geriatric assessment.
OUTLINE:
Patients receive nab-paclitaxel intravenously (IV) over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope medical
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Lancaster, California, United States, 93534
- City of Hope Antelope Valley
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South Pasadena, California, United States, 91030
- City of Hope South Pasadena
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Locally advanced or metastatic breast cancer
- Any estrogen receptor (ER), progesterone receptor (PR), or human epidermal growth factor receptor 2 (Her2neu) status as long as the patient will receive nab-paclitaxel alone
- First or second line chemotherapy treatment for metastatic disease
- Karnofsky performance status (KPS) >= 70%
- Resolution of grade >= 2 toxicity from prior therapy (other than alopecia)
- Peripheral neuropathy =< grade 1
- Absolute neutrophil count >= 1,500/mm^3
- Platelets >= 100,000 cells/mm^3
- Hemoglobin (Hb) >= 9.0 g/dl
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal
- Alkaline phosphatase =< 2.5 x upper limit of normal unless bone metastasis are present in the absence of liver metastases
- Bilirubin =< 1.5 mg/dl
- Creatinine clearance (calculated or 24 hour) >= 30 ml/min
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients may not be receiving any other investigational agents
- Untreated central nervous system (CNS) metastases or symptomatic CNS metastases requiring escalating doses of corticosteroids
- Known history of allergic reactions to paclitaxel
- Presence of any serious or uncontrolled infection
- Receipt of a taxane for adjuvant therapy or metastatic disease in the last 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (nab-paclitaxel)
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Correlative studies
Ancillary studies
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
Time Frame: During and after treatment, up to 2.5 years
|
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment.
|
During and after treatment, up to 2.5 years
|
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
Time Frame: On treatment, 28 days per cycle up to 30 months
|
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to treatment.
|
On treatment, 28 days per cycle up to 30 months
|
Rate of Participants With a Dose Reduction
Time Frame: On treatment, up to 30 months
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
|
On treatment, up to 30 months
|
Rate of Participants Requiring Dose Holds
Time Frame: While on treatment, up to 30 months
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
|
While on treatment, up to 30 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Determined by Response Evaluation Criteria in Solid Tumors
Time Frame: Up to 2.5 years
|
Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for objective response rate (complete response [CR] + partial response [PR]). RECIST: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Additionally, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study |
Up to 2.5 years
|
Median Progression Free Survival (PFS)
Time Frame: From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
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PFS will be estimated using the product limit method of Kaplan and Meier.
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From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 years
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Cancer-specific Geriatric (CARG) Assessment
Time Frame: CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
|
General linear models and descriptive methods will be used to explore factors as identified by a CARG assessment that may be predictive of toxicity (grade 3 or higher adverse events) or dose reduction. The cancer specific geriatric assessment score includes an evaluation of functional status, co-morbidity, cognition, psychological stats, social functioning and support, and nutritional status. It assesses a patient's age, gender, height, weight, cancer type, dosage, number of chemotherapy agents, hemoglobin, hearing, number of falls in past 6 months, able to take own medicine, whether walking is limited, have physical or emotional problems interfered with social activities and serum creatinine. Scores can range from 0 to to 1, with a higher score indicating higher risk of chemotherapy toxicity. Scores from 0 to 5 are considered low risk, 6 to 9 are considered intermediate risk, and 10 to 19 are considered high risk. |
CARG measured prior to treatment, toxicities and dose reduction measured up to 30 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mina Sedrak, City of Hope Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Breast Neoplasms
- Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- 11139 (Other Identifier: City of Hope Comprehensive Cancer Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2011-03295 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 118196
- 124494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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