Status:
TERMINATED
Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
Lead Sponsor:
Western Regional Medical Center
Conditions:
Pancreatic Carcinoma Non-resectable
Stage IV Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly schedule of gemcitabine plus nab-Pacitaxel for the treatment of unresectable/metastatic pancreatic cance...
Detailed Description
This study will help determine whether the occurrence of adverse events can be decreased by moving to a bi-weekly, opposed to a weekly, dosing schedule of gemcitabine plus nab-Pacitaxel for the treatm...
Eligibility Criteria
Inclusion
- Patients must have histologically-proven unresectable/metastatic pancreatic adenocarcinoma.
- Patient has one or more radiographically measurable tumor.
- Patients may have received prior adjuvant chemotherapy or radiation therapy (RT).
- Age ≥ 18 years.
- Patient must have read, understood, and provided written informed consent and HIPAA authorization after full explanation of the nature of the study.
- ECOG performance status 0 - 2 and an expected survival of at least 3 months.
- Acceptable hematological parameters within 2 weeks of commencing study therapy as follows:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Hemoglobin (Hgb) ≥ 9g/dl
- Patients with adequate organ function as measured by:
- A. Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.
- B. Hepatic: Bilirubin ≤ 2.0 mg/ and ALT and AST ≤ 1.5x the upper limit of normal.
- C. Renal: Creatinine ≤ 1.5 mg/dl and no other chronic kidney disease.
- Women must meet one of the following criteria:
- Post-menopausal for at least one year
- Surgically incapable of child-bearing
- Utilizing a reliable form of contraception for the duration of study participation. Women of child-bearing potential must have a negative serum β-HCG within 7 days of study drug administration.
Exclusion
- Previous use of nab-Paclitaxel for treatment of pancreatic cancer either as monotherapy or combination in neo-adjuvant, adjuvant, or the metastatic setting.
- Previous use of any chemotherapy or radiation therapy for metastatic disease.
- Patient has known brain metastases, unless previously treated and well-controlled for at least 3 months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart).
- Other significant active or chronic infection.
- History of active other malignancy excluding basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
- Pregnant or nursing females.
- Patient has serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the patient's safety or the study data integrity.
- Major surgery, other than diagnostic surgery within 4 weeks of study entry.
- Patient requires a legal authorized representative for consenting.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01851174
Start Date
February 1 2013
End Date
January 1 2015
Last Update
February 7 2018
Active Locations (1)
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1
Western Regional Medical Center
Goodyear, Arizona, United States, 85338