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

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00691054

Run by

University of Miami

People needed

20

Starts

2008-06-01

Expected to finish

2012-12-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States
• Johns Hopkins Singapore International Medical Centre — Singapore, Singapore

Full record on ClinicalTrials.gov

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