Status:
COMPLETED
Abraxane Therapy in Patients With Pancreatic Cancer Who Failed First-Line Gemcitabine Therapy
Lead Sponsor:
University of Miami
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 stopp...
Detailed Description
OBJECTIVES: Primary * To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00691054
Start Date
June 1 2008
End Date
December 1 2012
Last Update
May 11 2017
Active Locations (2)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
2
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 119074