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

Phase 2

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Abraxane	Abraxane	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.

Primary Outcome Measures

Name	Time	Method
Overall Survival Rate at 6 Months	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

Name	Time	Method
Number of Participants Showing Complete or Partial Response	6 months	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	12 months	Number of participants showing stable disease according to RECIST 1.0 criteria
Progression-free Survival	6 months	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	6 months
Median Overall Survival of Participants	12 months	Median overall survival rate of participants measured in months

Locations (2): Johns Hopkins Singapore International Medical Centre
🇸🇬
Singapore, Singapore
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸
Miami, Florida, United States