Status:
WITHDRAWN
Phase II Study of NGC-Triple Regimen in Potentially Resectable Pancreatic Cancer Patients
Lead Sponsor:
Pancreatic Cancer Research Team
Collaborating Sponsors:
Celgene
Conditions:
Resectable Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a phase II multi-center study of nab-paclitaxel, gemcitabine and cisplatin (NGC triple regimen) as preoperative therapy in potentially resectable pancreatic cancer patients. DISEASE STATE * ...
Detailed Description
The purpose of this study is to find out if the study drugs nab-paclitaxel, cisplatin, and gemcitabine given together are safe and effective. The combination of nab-paclitaxel plus gemcitabine has bee...
Eligibility Criteria
Inclusion
- Major Inclusion Criteria for the Study Include the Following:
- Patient has an ECOG performance status PS 0-1. No prior chemotherapy or radiation for pancreatic cancer and no prior exposure to gemcitabine and/or nab-paclitaxel
- Patient has the following blood counts at baseline:
- ANC ≥1.5 × 109/L (1500 /mm3)
- Platelets ≥100 × 109/L; (100,000/mm3)
- Hgb ≥10 g/dL
- Patient has the following blood chemistry levels at baseline:
- AST (SGOT), ALT (SGPT) ≤ 3.0 × upper limit of normal (ULN)
- Alkaline phosphatase (AP) ≤3.0 X ULN
- Total bilirubin ≤1.5 or ≤ULN
- Serum creatinine ≤1.5mg/dL or calculated clearance ≥50 mL/min/1.73 m2 for patients with serum creatinine levels \>1.5 mg/dL
- Patient has acceptable coagulation status as indicated by a PT within normal limits (± 15%) and PTT within normal limits (± 15%)
- Major Exclusion Criteria include the Following:
- Patient has locally advanced unresectable pancreatic cancer.
- Patients aged \>75.
- Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible.
- Patient uses therapeutic Coumadin for a history of pulmonary emboli or DVT.
- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Patient has known infection with HIV, hepatitis B, or hepatitis C.
- Patient has undergone major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ) within 4 weeks prior to Day 1 of treatment in this study.
- Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or nab-paclitaxel.
- Patient has a history of allergy or hypersensitivity to the study drugs.
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Exclusion
Key Trial Info
Start Date :
August 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03392571
Start Date
August 15 2018
End Date
December 30 2020
Last Update
May 7 2019
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