Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer
- Registration Number
- NCT02043288
- Lead Sponsor
- Orient Europharma Co., Ltd.
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NC-6004 and Gemcitabine combination NC-6004 NC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively NC-6004 and Gemcitabine combination Gemcitabine NC-6004 90mg/m2 i.v. on Day 1 and Gemcitabine 1000mg/m2 i.v. on Day 1 and Day 8 respectively Gemcitabine monotherapy Gemcitabine Gemcitabine 1000mg/m2 i.v. on Day 1 ,8 and 15
- Primary Outcome Measures
Name Time Method Overall survival (OS) 3.5 years Overall survival is defined as the time from the treatment initiation until death from any cause, and censored at the last follow up time.
- Secondary Outcome Measures
Name Time Method Quality of life (QoL) using EORTC QLQ-C30 3.5 years Quality of life (QoL) values and changes from baseline will be summarized.
CA19-9 3.5 years CA19-9 values and changes from baseline will be summarized.
Duration of response 3.5 years * 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.Response rate (RR) and disease control rate (DCR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria 3.5 years * 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.Progression free survival (PFS) 3.5 years Progression free survival is defined as the time from the treatment initiation until progression or death, and censored at the last follow up time.
Trial Locations
- Locations (43)
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Aichi Cancer Center
🇯🇵Aichi, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Shikokuchūō, Japan
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