Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abraxane
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
- Patients have to be 18 years-old or older
- Able to give signed Informed consent
Adequate end-organ function with laboratory parameters as follows:
- Neutrophils: 1.5 x10^9/L or greater
- Plts: 100 x10^9/L or greater
- Hemoglobin: ≥ 9.0g/dL
- Serum Creatinine: ≤ 1.5mg/dL
- Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN)
- Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN
- Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
- Measurable or non-measurable disease by RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
- Life expectancy greater than 3 months
- Willing and able to comply with the protocol requirement.
- Patients must not have any peripheral neuropathy equal or greater than grade 2
Exclusion Criteria:
- Chemotherapy within 3 weeks prior to enrollment
- Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
- Any major surgery within 4 weeks prior to enrollment
- Peripheral neuropathy equal to or greater than grade 2
- Clinical AIDS or known positive HIV serology
- Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 3 months
- History of stroke within 3 months
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study
- Pregnant (positive pregnancy test) or lactating
- Inability to comply with study and/or follow-up procedures
- Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
- Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.
Sites / Locations
- University of Miami Sylvester Comprehensive Cancer Center - Miami
- Johns Hopkins Singapore International Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abraxane
Arm Description
One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
Outcomes
Primary Outcome Measures
Overall Survival Rate at 6 Months
Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.
Secondary Outcome Measures
Number of Participants Showing Complete or Partial Response
Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, 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.
Number of Participants Showing Stable Disease
Number of participants showing stable disease according to RECIST 1.0 criteria
Progression-free Survival
Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Number of Participants Experiencing Adverse Events
Median Overall Survival of Participants
Median overall survival rate of participants measured in months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00691054
Brief Title
Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
Official Title
Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.
Detailed Description
OBJECTIVES:
Primary
To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen.
Secondary
To determine the safety and characterize the toxicity profile of this drug.
To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease.
To determine CA 19-9 response.
To determine progression-free survival.
OUTLINE: This is a multicenter study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abraxane
Arm Type
Experimental
Arm Description
One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
Intervention Type
Drug
Intervention Name(s)
Abraxane
Other Intervention Name(s)
Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Intervention Description
One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment
Primary Outcome Measure Information:
Title
Overall Survival Rate at 6 Months
Description
Overall survival was measured from the start of treatment (date of first dose of Abraxane® therapy) to date of death due to any cause. For patients who are alive, follow-up time will be censored at date of last contact.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants Showing Complete or Partial Response
Description
Number of participants showing complete or partial response to protocol therapy according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, 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.
Time Frame
6 months
Title
Number of Participants Showing Stable Disease
Description
Number of participants showing stable disease according to RECIST 1.0 criteria
Time Frame
12 months
Title
Progression-free Survival
Description
Median number of months participants experienced progression-free survival, according to Response Evaluation Criteria In Solid Tumors(RECIST) v1.0 criteria for target lesions and assessed by CT/MRI. Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
6 months
Title
Number of Participants Experiencing Adverse Events
Time Frame
6 months
Title
Median Overall Survival of Participants
Description
Median overall survival rate of participants measured in months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
Patients have to be 18 years-old or older
Able to give signed Informed consent
Adequate end-organ function with laboratory parameters as follows:
Neutrophils: 1.5 x10^9/L or greater
Plts: 100 x10^9/L or greater
Hemoglobin: ≥ 9.0g/dL
Serum Creatinine: ≤ 1.5mg/dL
Bilirubin: ≤ 1.5 times the upper limit of the normal range (ULN)
Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times ULN
Adequate contraception: For female (or male) patients, either post-menopausal, or for pre-menopausal surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
Measurable or non-measurable disease by RECIST criteria
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
Life expectancy greater than 3 months
Willing and able to comply with the protocol requirement.
Patients must not have any peripheral neuropathy equal or greater than grade 2
Exclusion Criteria:
Chemotherapy within 3 weeks prior to enrollment
Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
Any major surgery within 4 weeks prior to enrollment
Peripheral neuropathy equal to or greater than grade 2
Clinical AIDS or known positive HIV serology
Evidence of concurrent, clinically evident malignancy, except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years
Unstable angina
New York Heart Association (NYHA) Grade II or greater congestive heart failure
History of myocardial infarction within 3 months
History of stroke within 3 months
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study
Pregnant (positive pregnancy test) or lactating
Inability to comply with study and/or follow-up procedures
Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caio Max S. Rocha Lima, MD
Organizational Affiliation
University of Miami Sylvester Comprehensive Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gilberto Lopes, MD
Organizational Affiliation
Johns Hopkins Singapore International Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Sylvester Comprehensive Cancer Center - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Johns Hopkins Singapore International Medical Centre
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
22307213
Citation
Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A phase II trial of nab-Paclitaxel as second-line therapy in patients with advanced pancreatic cancer. Am J Clin Oncol. 2013 Apr;36(2):151-6. doi: 10.1097/COC.0b013e3182436e8c.
Results Reference
result
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Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
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