MASCARPONE study

Phase 2

Recruiting

Conditions: rare fractions of hepato-pancreato-biliary cancer and neuroendocrine tumor
Undifferentiated carcinoma of the pancreas, acinar cell carcinoma of the pancreas, pancreatic cancer, UGT1A1 polymorphism

Registration Number: JPRN-jRCTs031220099

Lead Sponsor: Ikeda Masafumi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Cohort A
(1) Pathologically confirmed undifferentiated carcinoma of the pancreas;
(2) Unresectable disease diagnosed by contrast-enhanced CT (chest, abdomen, and pelvis) and/or MRI (abdomen and pelvis) imaging;
*If the patient received adjuvant chemotherapy and the diasese recurred within 6 months after the completion, the patient is excluded from this study.
(3) At least 20 years of age;
(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
(5) Measurable disease by RECIST v1.1 criteria;
(6) No prior treatment for undifferentiated carcinoma of the pancreas;
(7) Adequate hematologic and organ function defined by the following laboratory test results, obtained within 7 days prior to study enrollment:
1) Absolute neutrophil count (ANC) >=1,500 /mm3,
2) Hemoglobin >= 8.0 g/dL,
3) Platelet count >= 10^4/mm3,
4) Serum total bilirubin <= 2.0 mg/dL,
5) Aspartate transaminase (AST) < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
6) Alanine transaminase (ALT) < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
7) Serum creatinine (Cr) >= 1.2 mg/dL
(8) Signed written informed consent form.

Cohort B
(1) Pathologically confirmed acinar cell carcinoma of the pancreas;
(2) Unresectable disease diagnosed by contrast-enhanced CT (chest, abdomen, and pelvis) and/or MRI (abdomen and pelvis) imaging;
*If the patient received adjuvant chemotherapy and the diasese recurred within 6 months after the completion, the patient is excluded from this study.
(3) 20-75 years of age;
(4) ECOG performance status of 0-1;
(5) Measurable disease by RECIST v1.1 criteria;
(6) No prior treatment for acinar cell carcinoma of the pancreas;
(7) Peripheral motor or sensory neuropathy <= grade 1;
(8) None of UGT1A1 polymorphisms (UGT1A1*6/*6, UGT1A1*28/*28, and UGT1A1*6/*28);
(9) Adequate hematologic and organ function defined by the following laboratory test results, obtained within 7 days prior to study enrollment:
1) Absolute neutrophil count (ANC) >=1,500 /mm3,
2) Hemoglobin >= 8.0 g/dL,
3) Platelet count >= 10^4/mm3,
4) Serum total bilirubin <= 1.5 mg/dL,
5) AST < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
6) ALT < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
7) Cr >= 1.2 mg/dL
(10) Signed written informed consent form.

Cohort C
(1) Pathologically confirmed adenocarcinoma;
(2) Metastatic or recurrent* pancreatic cancer diagnosed diagnosed by contrast-enhanced CT (chest, abdomen, and pelvis) and/or MRI (abdomen and pelvis) imaging;
*If the patient received adjuvant chemotherapy and the diasese recurred within 6 months after the completion, the patient is excluded from this study.
(3) Presence of UGT1A1 polymorphisms (UGT1A1*6/*6, UGT1A1*28/*28, and UGT1A1*6/*28);
(4) 20-75 years of age;
(5) ECOG performance status of 0-1;
(6) Measurable disease by RECIST v1.1 criteria;
(7) No prior treatment for pancreatic cancer;
(8) Peripheral motor or sensory neuropathy <= grade 1;
(9) Adequate hematologic and organ function defined by the following laboratory test results, obtained within 7 days prior to study enrollment:
1) Absolute neutrophil count (ANC) >=1,500 /mm3,
2) Hemoglobin >= 8.0 g/dL,
3) Platelet count >= 10 x 10^4/mm3,
4) Serum total bilirubin <= 2.0 mg/dL,
5) AST < 100 U/L without liver metastases (< 150 U/L is acceptable if liver metastases are present),
6)

Exclusion Criteria

(1)History of malignancy (except for adequately treated carcinoma in situ, non-invasive cancer) within 2 years prior to study entry except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 2 years;
(2)Evidence of uncontrolled, active infection, requiring anti-infectious treatment, except for viral hepatitis;
(3)Known central nervous system metastases (imaging required only if participants are symptomatic);
(4)Symptomatic ascites or pleural effusion;
(5)Significant lung disease, including interstitial lung disease, pulmonary fibrosis, or severe emphysema;
(6)Active watery diarrhea;
(7)Pregnant, lactating or females of childbearing age unless using highly effective contraception;
(8)Male with partner of child-bearing potential unless using highly effective contraception;
(9)Patients with significant psychiatric disorder;
(10)History of arterial thromboembolism (e.g., myocardial infarction, unstable angina, and cerebral infarction) within 6 months prior to the initiation of study treatment,
(11)Significant comorbidities, such as uncontrolled diabetes mellitus, uncontrolled hypertension, New York Heart Association (NYHA) Class III or greater cardiac disease, chronic kidney disease, or liver dysfunction;
(12)Requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication
(13)History of hypersensitivity to the study drugs used in each cohort;
(14)Patients whose entry in the study is considered by the investigator to be inappropriate.