A Phase II Randomized Study of Gemcitabine and Nab-paclitaxel in Combination With S- 1/LV (GASL) or Oxaliplatin (GAP) as First-line Treatment for Metastatic Pancreatic Cancer
Gemcitabine 1000 mg: Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.
Nab paclitaxel: Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
S1: S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:
* BSA \< 1.25 m2: 60 mg/day
* 1.25 m2 ≤ BSA \< 1.5 m2: 80 mg/day
* BSA ≥ 1.5 m2: 100 mg/day
leucovorin: leucovorin 30mg BID day 1 to 7 on in a 2-week cycle
Oxaliplatin: Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days
Study summary
Gemcitabine and nab-paclitaxel are one standard of care for metastatic pancreatic adenocarcinoma (mPDAC) but the progression free survival (PFS) of the regimen is only 5.5 months. Previous phase II study showed gemcitabine and nab-paclitaxel plus cisplatin had a PFS of 10.1 months in mPDAC. This study will evaluate the efficacy and safety of gemcitabine, nab-paclitaxel plus S-1/LV (GASL) against gemcitabine, nab-paclitaxel plus oxaliplatin (GAP) in patients with mPDAC.
Eligibility
Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* A.Cytology or histology confirmed pancreatic adenocarcinoma with evidence of distant metastasis.Mixed component of other cell type (eg, adenosquamous, adenocarcinoma with neuroendocrine differentiation) is eligible but should notify PI before registration.
* B.No history of prior chemotherapy for pancreatic cancer, except adjuvant chemotherapy that completed at least 6 months before documentation of recurrence by imaging study.
* C.Patients with prior radiotherapy are eligible if there are other measurable target lesions that is not irradiated.
* D.At least one measurable lesion according to RECIST version 1.1
* E.Ability to understand and willingness to sign a written informed consent document.
* F.ECOG performance status 0-1
* G.Age of 20 years or above
* H.Adequate organ function as defined by the following criteria:
absolute neutrophil count (ANC) ≥ 1,500/mm3 hemoglobin level ≥ 9 g/dL platelet count ≥ 100,000/mm3 total bilirubin ≤ 2 ULN or ≤5 ULN if caused by biliary obstruction and achieving adequate drainage judged by investigator aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 x ULN or ≤ 5.0×ULN in the presence of liver metastases creatinine clearance rate (CCr) ≥ 50 mL/min (24-hour urine collection or calculated by Cockroft-Gault formula; male: \[(140 - age) × weight (kg)\]/\[72 × serum creatinine(mg/dL)\];female=male x 0.85
-I.Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.
Exclusion Criteria:
* A. Other malignancy within the past 5 years except for adequately treated localized cancer or carcinoma in situ;All patients with other malignancy within the past 5 years should notify PI before registration.
* B.Active or uncontrolled infection;
* C.Significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications at physician discretion
* D.Pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential.
* E.History of active autoimmune disease within 3 years or use of steroid more than prednisolone 10mg/day.
Primary outcome measure(s)
Best objective response rate (ORR) — 6 years tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Trial sites (4)
Facility
City
Region
Status
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Taiwan
China Medical University Hospital
Taichung
Taiwan
Taichung Veterans General Hospital
Taichung
Taiwan
National Cheng Kung University Hospital
Tainan
Taiwan
More National Health Research Institutes, Taiwan trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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