Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Abraxane® in the Treatment of Patients With Pancreatic Cancer Who Have Failed First-Line Treatment With Gemcitabine-Based Therapy

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Abraxane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abraxane<br>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. | Drug: Abraxane<br>* 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<br>* Other names: Paclitaxel Albumin-Stabilized Nanoparticle Formulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| Number of Participants Showing Stable Disease | Number of participants showing stable disease according to RECIST 1.0 criteria | 12 months | 
| 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. | 6 months | 
| Number of Participants Experiencing Adverse Events |  | 6 months | 
| Median Overall Survival of Participants | Median overall survival rate of participants measured in months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer