Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to determine the maximal tolerated dose (MTD) of Oxaliplatin in this phase I study. The secondary objectives are to determine the response rate, progression free survival, overall survival, and safety profiles.

Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: National Cheng-Kung University Hospital; National Taiwan University Hospital
• Treatments: Albumin-Bound Paclitaxel; Oxaliplatin; Paclitaxel; Tegafur

Criteria

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma or carcinoma of the stomach, pancreas and biliary tract with unresectable, recurrence or metastatic disease.

• No prior systemic chemotherapy except adjuvant chemotherapy that has completed 6 months prior enrollment.

• Palliative RT to bone but not the primary, main tumor site is permitted.

• At least one measurable lesion over non-radiated site.

• Aged between 20 to 70 years old.

• ECOG Performance Status <= 1.

• Life expectancy greater than 12 weeks.

• Adequate bone marrow function : absolutely neutrophil count >= 1.5 x 109/L or WBC >= 4 x 109/L, hemoglobin >= 9 g/dl, platelet count 100 x 109/L

• Adequate liver function : ALT <= 2.5 x ULN and Bilirubin < 1.5 x ULN

• Adequate renal function: creatinine < 1.5 x ULN and calculated eGFR> 50 mL/min.

Exclusion Criteria:

• Major surgery within four weeks prior to study enrolment.

• Patient with Ampulla vater cancer is excluded.

• Patients with suspicious or history of CNS metastasis.

• Patients who with active or uncontrolled infections.

• Patients who have history of myocardial infarction or unstable angina within 6 months before entry.

• Patients with concomitant illness that might be aggravated by chemotherapy.

• Patients who are pregnant or with breast feeding.

• Other concomitant or previously malignancy within 3 yrs except for in situ cervix cancer or squamous cell carcinoma of the skin, stage 0-I colon or breast treated by surgery only and without evidence of relapsed tumor.

• Mental status is not fit for clinical trial

• Fertile men and women unless using a reliable and appropriate contraceptive method.