Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer
Pancreatic Neoplasms
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Pancreatic cancer, Platinum, Micelle
Eligibility Criteria
Inclusion criteria:
- Male or female aged between 20 to 80 years (inclusive)
- Unresectable, histologically or cytologically confirmed, locally advanced or metastatic pancreatic cancer (adenocarcinoma, adenosquamous carcinoma or poorly differentiated carcinoma)
- Presence of at least one measurable tumor lesion (longest diameter ≥ 10 mm)
No prior systemic anti-cancer therapy* and radiotherapy** for advanced pancreatic cancer
* Patients with post-operative adjuvant chemotherapy other than platinum products (e.g. cisplatin, carboplatin and oxaliplatin, etc.) or radiotherapy or chemo-radiotherapy completed more than 6 months before recurrence will be eligible.
** Patients with prior palliative radiotherapy of < 20% bone marrow involvement prior to 6 months from screening will be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Adequate organ function defined as:
- 3,000 cells/μL ≤ WBC ≤ 12,000 cells/μL
- Absolute neutrophils count (ANC) ≥ 1,500 cells/μL
- Platelets ≥ 100,000 cells/μL
- Hemoglobin (Hb) ≥ 9.0 g/dL
- Alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤ 2.5 times the upper limit of normal (ULN) in patients with no demonstrable hepatic metastasis, or ≤ 5 x ULN in patients with hepatic metastasis
- Serum bilirubin ≤ 1.5 x ULN in patients with no demonstrable hepatic metastasis and obstructive jaundice, or ≤ 2.5 x ULN in patients with hepatic metastasis or obstructive jaundice
- Serum creatinine (SCr) ≤ 1.5 mg/dL and creatinine clearance (CrCl) ≥ 60 mL/min (from 24-hour urine test or Cockcroft-Gault formula)
- Corrected serum calcium ≤ ULN
If fertile*, willing to use barrier contraception till 6 months after the end of treatment
* With the following exceptions: 1) pre-menopausal females with bilateral tubal ligation, bilateral oophorectomy or hysterectomy; 2) post-menopausal women, defined as 12 months of spontaneous amenorrhea; 3) males with vasectomy.
- Willing and able to comply with study procedures and provide written informed consent
Exclusion criteria:
- Pregnancy or breastfeeding
- Active concomitant malignancy or history of other cancer except carcinoma in situ of cervical squamous cell carcinoma, stage I colon cancer or other malignance that has remained disease-free for more than 3 years after curative intervention
- Metastasis to the central nervous system or brain
Evidence of hearing impaired ≥ Grade 2 as assessed by pure tone audiometry or other neurotoxicity ≥ Grade 2
* Patients with age-associated hearing loss at the high frequencies that, in the judgment of the investigator, would not interfere significantly with patient's safety or study assessments will be eligible to enroll.
- Patient with pulmonary fibrosis or interstitial pneumonia
- Marked pleural effusion or ascites above Grade 2
- Patient with known HIV infection
- Patient with active hepatitis B, hepatitis C or any other ongoing severe infections
- Patient with severe mental disorder
- As judged by the investigator, any evidence of significant laboratory findings or severe/uncontrolled clinical disorders (e.g. dementia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, active cardiomyopathy, unstable arrhythmia, and other unstable or uncompensated respiratory, cardiac, hepatic, renal and/or infectious disease)
- Patient with known hypersensitivity to Pt compounds
- Known severe drug hypersensitivity
- Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment
Alcoholic liver disease* or liver disease with obvious clinical symptom or sign
* the investigator should judge from medical examination by interview and laboratory test including γ-GTP, AST and ALT
Daily Alcohol consumption within 6 months before the screening as an average weekly intake of >21 units (168 g of pure alcohol) or an average daily intake of >3 units (24 g of pure alcohol) for males / an average weekly intake of >14 units (112 g of pure alcohol) or an average daily intake of >2 units (16 g of pure alcohol) for females.
Kind of Alcohol Alcohol Percentage mL per 1 unit =8 g of pure alcohol
Beer 5 % 200 mL
Whiskey/Brandy 40 % 25 mL
Wine 12 % approx. 83 mL
Sake 15 % approx. 67 mL
Distilled spirit 25 % 40 mL
Kaoliang 50 % 20 mL
- Patient with uncontrolled diabetes
- Radiotherapy within 6 months before screening
- Experienced Abdominal Radiotherapy
- Experienced treatment of Gemtuzumab ozogamicin
- Patient with autoimmune hepatitis or idiopathic thrombocytopenic purpura (ITP)
- Observation of "attenuated or reversed hepatic venous portal blood flow*" was confirmed by doppler ultrasonography or CT (recommend evaluation in arterial phase, portal-venous phase and equilibrium phase) of the liver * On doppler ultrasonography of right and left branch of portal vein, blood flow is measured as about 0 mL/min or between plus and minus, which indicate obvious blood flow obstruction
Sites / Locations
- Prince of Wales Hospital
- Queen Mary Hospital
- Aichi Cancer Center
- Chiba Cancer Center
- National Hospital Organization Kyushu Cancer Center
- Hokkaido University Hospital
- National Hospital Organization Osaka National Hospital
- Osaka Medical Center for Cancer and Cardiovascular Diseases
- Saitama Cancer Center
- National Hospital Organization Shikoku Cancer Center
- Shizuoka Cancer Center
- Center Hospital of the National Center for Global Health and Medicine
- Kyorin university Hospital
- National Cancer Center Hospital East
- National Cancer Center Hospital
- The Cancer Institute Hospital of JFCR
- The University of Tokyo Hospital
- Kanagawa Cancer Center
- Ajou University Hospital (AUH)
- Samsung Medical Center (SMC)
- The Catholic University of Korea, Seoul St. Mary's Hospital (CUK SSMH)
- Korea University Guro Hospital (KUGH)
- Yonsei University Health System, Severance Hospital
- Hospital Sultan Ismail
- Hospital Kuala Lumpur
- Makati Medical Center
- National Cancer Centre
- Chiayi Chang Gung Memorial Hospital
- Kaohsiung Medical University Hospital
- Chang Gung Memorial Hospital, Kaohsiung Branch
- China Medical University Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- Chi Mei Hospital
- Mackay Memorial Hospital
- National Taiwan University Hospital
- Taipei Medical University Hospital
- Koo Foundation Sun Yat-Sen Cancer Center
- Taipei Veterans General Hospital
- Tri-Service General Hospital
- Taipei Medical University-Shuang-Ho Hospital, Ministry of Health and Welfare
- Chang Gung Memorial Hospital, Linkou Branch
- Chi Mei Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
NC-6004 and Gemcitabine combination
Gemcitabine monotherapy
NC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively
Gemcitabine 1000mg/m2 i.v. on Day 1 ,8 and 15