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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami; University of Miami Sylvester Comprehensive Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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.