Clinical trial NCT03401827: The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
Official title: The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatic Adenocarcinoma
Chemotherapy Effect
Keywords: pancreatic cancer
second line chemotherapy
nab-paclitaxel
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pancreatic cancer is a very poor prognosis and has a high mortality rate. The clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. Gemcitabine + nab-paclitaxel (GnP) as a second-line treatment after FOLFIRINOX may be expected to be considerable. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

Detailed description: Pancreatic cancer is a very poor prognosis and has a high mortality rate. It is not clear that the improvement of clinical outcome due to anticancer drugs is not clear compared to other carcinomas. In particular, the 5-year survival rate of metastatic pancreatic cancer is still only about 2%, and the clinical results have improved somewhat with the combination therapy of chemotherapy as the first-line treatment. However, effective secondary chemotherapy after these first-line treatment failures is limited. Meta-analysis has reported that life expectancy is significantly increased in patients receiving second-line chemotherapy after failure of primary chemotherapy. However, it is not yet clear which cancer treatment is most effective. In the NCCN guideline (ver. 2017.2), the second trial of chemotherapy for locally advanced or metastatic pancreatic cancer is the most recommended clinical trial.Recently, FOLFIRINOX has been used in patients with locally advanced or metastatic pancreatic cancer who have good performance in Korea. The response rate of the treatment is 30%, and many patients require secondary chemotherapy. In a practice guideline published by the American Society of Clinical Oncology, Gemcitabine + nab-paclitaxel(GnP) is the only recommended combination for patients failing primary treatment with FOLFIRINOX. In light of the results of previous reports, the efficacy of GnP as a second-line treatment after FOLFIRINOX may be expected to be considerable, but there is a lack of studies reporting GnP therapy on the second line after FOLFIRINOX failure as a first-line treatment. The aim of this study was to evaluate the efficacy of GnP as a second-line treatment after failed FOLFIRINOX treatment for locally advanced or metastatic pancreatic ductal adenocarcinoma.

Eligibility criteria: 1. Inclusion criteria

   1. Patient whose age is 20 years or older
   2. ECOG Performance Status 0-2
   3. Pathologically confirmed pancreatic adenocarcinoma
   4. Patients with locally advanced or distant metastasis status
   5. Patients who had undergone primary chemotherapy with previous FOLFIRINOX and whose disease progress was confirmed
   6. Patients whose consent was obtained (non-insurance agreement)
2. Exclusion Criteria

   1. Those who can not obtain consent
   2. Those who refuse chemotherapy
   3. ECOG Performance Status 3 or higher
   4. Multiple organ failure is accompanied
   5. Severe comorbidities other than cancer that do not expect a sufficient survival period over 1 month
   6. Allergy to the test drug

Primary outcomes:
measure: survival rate
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: till death or follow-up loss or end of study up to 2 years
measure: Progression free survival
timeFrame: till death or follow-up loss or end of study up to 2 years
measure: Disease control rate
timeFrame: 6 months
measure: adverse event
timeFrame: till death or follow-up loss or end of study up to 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang Hyub Lee, MD, Ph.D
role: STUDY_DIRECTOR
References:
citation: Huh G, Lee HS, Choi JH, Lee SH, Paik WH, Ryu JK, Kim YT, Bang S, Lee ES. Gemcitabine plus Nab-paclitaxel as a second-line treatment following FOLFIRINOX failure in advanced pancreatic cancer: a multicenter, single-arm, open-label, phase 2 trial. Ther Adv Med Oncol. 2021 Nov 10;13:17588359211056179. doi: 10.1177/17588359211056179. eCollection 2021.