The Effect of Gemcitabine Plus Nab-paclitaxel as Secondary Chemotherapy in Advanced Pancreatic Cancer

• ClinicalTrials.gov Identifier: NCT03401827
• Recruitment Status: Unknown
• First Posted: January 17, 2018
• Last Update Posted: February 12, 2018
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Sang Hyub Lee, Seoul National University Hospital

Tracking Information

• First Submitted Date: December 30, 2017
• First Posted Date: January 17, 2018
• Last Update Posted Date: February 12, 2018
• Estimated Study Start Date: March 1, 2018
• Estimated Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 16, 2018)

survival rate [ Time Frame: 6 months ]

survival rate at 6 months after 2nd line chemotherapy

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 16, 2018)

• overall survival [ Time Frame: till death or follow-up loss or end of study up to 2 years ]
  overall survival after 2nd line chemotherapy
• Progression free survival [ Time Frame: till death or follow-up loss or end of study up to 2 years ]
  duration till progression after 2nd line chemotherapy
• Disease control rate [ Time Frame: 6 months ]
  SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy
• adverse event [ Time Frame: till death or follow-up loss or end of study up to 2 years ]
  all reported adverse events after 2nd line chemotherapy

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pancreatic Adenocarcinoma
• Chemotherapy Effect

Intervention

Drug: Chemotherapy (Gemcitabine + nab-paclitaxel)

Nanoparticle albumin-bound paclitaxel (125 mg/m2) miv over 30 min, Day 1,8,15

Gemcitabine (1,000mg/m2) and N/S 150mL miv over 30 min, Day 1,8,15

Other Name: GnP

Study Arms

Experimental: Gemcitabine + nab-paclitaxel

Case with chemotherapy (Gemcitabine + nab-paclitaxel)

Intervention: Drug: Chemotherapy (Gemcitabine + nab-paclitaxel)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 16, 2018): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 1, 2019
• Estimated Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03401827
• Other Study ID Numbers: H-1710-067-894
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sang Hyub Lee, Seoul National University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul National University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Sang Hyub Lee, MD, Ph.D; Seoul National University Hospital

• PRS Account: Seoul National University Hospital
• Verification Date: January 2018