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

Launched by UNIVERSITY OF MIAMI · Jun 4, 2008

Keywords

ClinConnect Summary

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: Th...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have histologically confirmed, locally advanced (unresectable) or metastatic pancreatic cancer, and have failed first-line treatment with a gemcitabine-containing regimen.
• • 2. Patients have to be 18 years-old or older
• • 3. Able to give signed Informed consent
• 4. 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
• • 5. 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
• • 6. Measurable or non-measurable disease by RECIST criteria
• • 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• • 8. Patients must be at least 3 weeks from prior therapies and must have recovered from prior toxicity
• • 9. Life expectancy greater than 3 months
• • 10. Willing and able to comply with the protocol requirement.
• • 11. Patients must not have any peripheral neuropathy equal or greater than grade 2
• Exclusion Criteria:
• • 1. Chemotherapy within 3 weeks prior to enrollment
• • 2. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
• • 3. Any major surgery within 4 weeks prior to enrollment
• • 4. Peripheral neuropathy equal to or greater than grade 2
• • 5. Clinical AIDS or known positive HIV serology
• • 6. 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
• • 7. Unstable angina
• • 8. New York Heart Association (NYHA) Grade II or greater congestive heart failure
• • 9. History of myocardial infarction within 3 months
• • 10. History of stroke within 3 months
• • 11. 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
• • 12. Pregnant (positive pregnancy test) or lactating
• • 13. Inability to comply with study and/or follow-up procedures
• • 14. Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
• • 15. Participants cannot have been in another experimental drug study within 4 weeks of the first infusion of these study medications.