Combination Therapy With NC-6004 And Gemcitabine Versus Gemcitabine Alone In Pancreatic Cancer

Study Overview

Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer

This clinical trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer in Asian countries.

Pancreatic cancer is one of the most deadly cancers because of the predominately late diagnosis. Gemcitabine (GEM) is the standard treatment for advanced and metastatic pancreatic cancer. According to preclinical data and few early phase studies, a combined use of gemcitabine and cisplatin (CDDP) showed synergistic efficacy against pancreatic cancer. NC-6004, a novel micellar cisplatin formulation, retains the activity but avoids the renal toxicity and neurotoxicity caused by the high peak Cmax concentrations of cisplatin. This trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic cancer. The main hypothesis of this study is that NC-6004 plus gemcitabine combination is superior to gemcitabine alone in terms of overall survival in locally advanced or metastatic pancreatic cancer patients

Pancreatic Neoplasms

DRUG: NC-6004
DRUG: Gemcitabine

NC-6004-005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-01-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-04-14
First Submitted that Met QC Criteria 2014-01-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-04-15
First Posted (ACTUAL) 2014-01-23	Results First Posted N/A	Last Verified 2020-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: NC-6004 and Gemcitabine combination NC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively	DRUG: NC-6004 Study group (3 week/cycle): NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1 DRUG: Gemcitabine Study group (3 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004) Control group (4 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15
ACTIVE_COMPARATOR: Gemcitabine monotherapy Gemcitabine 1000mg/m2 i.v. on Day 1 ,8 and 15	DRUG: Gemcitabine Study group (3 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004) Control group (4 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: NC-6004 and Gemcitabine combination

NC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively

DRUG: NC-6004

Study group (3 week/cycle): NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1

DRUG: Gemcitabine

Study group (3 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004) Control group (4 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15

ACTIVE_COMPARATOR: Gemcitabine monotherapy

Gemcitabine 1000mg/m2 i.v. on Day 1 ,8 and 15

DRUG: Gemcitabine

Study group (3 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004) Control group (4 week/cycle): Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15

Primary Outcome Measures	Measure Description	Time Frame
Overall survival (OS)	Overall survival is defined as the time from the treatment initiation until death from any cause, and censored at the last follow up time.	3.5 years

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival (PFS)	Progression free survival is defined as the time from the treatment initiation until progression or death, and censored at the last follow up time.	3.5 years
Response rate (RR) and disease control rate (DCR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	* Response rate is defined as counts and proportions of patients responding complete response or partial response within the duration of the study. * Disease control rate is defined as counts and proportions of patients responding complete response, partial response or progressive disease within the duration of the study.	3.5 years
Duration of response	* Duration of overall response (DOR) will be measured from the time of initial response (CR or PR) until documented progression or death, and censored at last follow up time. * Duration of stable disease (DSD) will be measured from the time of initial stable disease (SD) until documented progression or death, and censored at last follow up time.	3.5 years
CA19-9	CA19-9 values and changes from baseline will be summarized.	3.5 years
Quality of life (QoL) using EORTC QLQ-C30	Quality of life (QoL) values and changes from baseline will be summarized.	3.5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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. 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 6. 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 7. 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. 8. Willing and able to comply with study procedures and provide written informed consent

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. 5. Patient with pulmonary fibrosis or interstitial pneumonia 6. Marked pleural effusion or ascites above Grade 2 7. Patient with known HIV infection 8. Patient with active hepatitis B, hepatitis C or any other ongoing severe infections 9. Patient with severe mental disorder 10. 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) 11. Patient with known hypersensitivity to Pt compounds 12. Known severe drug hypersensitivity 13. Treatment with a non-approved or investigational product within 30 days before Day 1 of study treatment 14. 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 15. 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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

NanoCarrier Co., Ltd.

Investigators

PRINCIPAL_INVESTIGATOR: Li-Tzong Chen, M.D., Ph. D., National Institute of Cancer Research, National Health Research Institutes

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record