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 CA19-9 3.5 years CA19-9 values and changes from baseline will be summarized.
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.
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.Quality of life (QoL) using EORTC QLQ-C30 3.5 years Quality of life (QoL) values and changes from baseline will be summarized.
Trial Locations
- Locations (43)
Yonsei University Health System, Severance Hospital
π°π·Seoul, Korea, Republic of
Chiba Cancer Center
π―π΅Chiba, Japan
Korea University Guro Hospital (KUGH)
π°π·Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital (CUK SSMH)
π°π·Seoul, Korea, Republic of
Samsung Medical Center (SMC)
π°π·Seoul, Korea, Republic of
Hokkaido University Hospital
π―π΅Hokkaido, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
π―π΅Osaka, Japan
Saitama Cancer Center
π―π΅Saitama, Japan
Kanagawa Cancer Center
π―π΅Yokohama, Japan
Ajou University Hospital (AUH)
π°π·Gyeonggi-do, Korea, Republic of
National Cancer Centre
πΈπ¬Singapore, Singapore
Hospital Kuala Lumpur
π²πΎKuala Lumpur, Malaysia
Chiayi Chang Gung Memorial Hospital
π¨π³Chiayi City, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
π¨π³Taipei, Taiwan
Prince of Wales Hospital
ππ°Hong Kong, Hong Kong
Shizuoka Cancer Center
π―π΅Shizuoka, Japan
The University of Tokyo Hospital
π―π΅Tokyo, Japan
Aichi Cancer Center
π―π΅Aichi, Japan
National Hospital Organization Kyushu Cancer Center
π―π΅Fukuoka, Japan
National Hospital Organization Osaka National Hospital
π―π΅Osaka, Japan
National Hospital Organization Shikoku Cancer Center
π―π΅ShikokuchΕ«Ε, Japan
The Cancer Institute Hospital of JFCR
π―π΅Tokyo, Japan
Center Hospital of the National Center for Global Health and Medicine
π―π΅Tokyo, Japan
Kyorin university Hospital
π―π΅Tokyo, Japan
National Cancer Center Hospital East
π―π΅Tokyo, Japan
National Cancer Center Hospital
π―π΅Tokyo, Japan
Makati Medical Center
π΅πMakati, Philippines
Hospital Sultan Ismail
π²πΎJohor Bahru, Malaysia
Kaohsiung Medical University Hospital
π¨π³Kaohsiung, Taiwan
Chang Gung Memorial Hospital, Kaohsiung Branch
π¨π³Kaohsiung, Taiwan
China Medical University Hospital
π¨π³Taichung, Taiwan
Taichung Veterans General Hospital
π¨π³Taichung, Taiwan
Chi Mei Hospital
π¨π³Tainan, Taiwan
National Cheng Kung University Hospital
π¨π³Tainan, Taiwan
National Taiwan University Hospital
π¨π³Taipei, Taiwan
Chi Mei Medical Center
π¨π³Yongkang, Taiwan
Mackay Memorial Hospital
π¨π³Taipei, Taiwan
Taipei Medical University Hospital
π¨π³Taipei, Taiwan
Tri-Service General Hospital
π¨π³Taipei, Taiwan
Taipei Veterans General Hospital
π¨π³Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou Branch
π¨π³Taipei, Taiwan
Taipei Medical University-Shuang-Ho Hospital, Ministry of Health and Welfare
π¨π³Taipei, Taiwan
Queen Mary Hospital
ππ°Hong Kong, Hong Kong