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

NCT ID: NCT03401827

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2019-01-01

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.

Conditions

Pancreatic Adenocarcinoma; Chemotherapy Effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gemcitabine + nab-paclitaxel

Case with chemotherapy (Gemcitabine + nab-paclitaxel)

Group Type: EXPERIMENTAL

Chemotherapy (Gemcitabine + nab-paclitaxel)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

GnP

Eligibility Criteria

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)

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Hyub Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Hyub Lee, MD, Ph.D

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jin Ho Choi, MD

Role: CONTACT

pseudo.jh@gmail.com

82-2-2072-2228

Sang Hyub Lee, MD, Ph.D

Role: CONTACT

gidoctor@korea.com

82-2-2072-2228

Facility Contacts

Sang Hyub Lee, MD. PhD.

Role: primary

gidoctor@snuh.org

+82-2-2072-4892

References

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.

Reference Type: DERIVED

PMID: 34790261 (View on PubMed)

Other Identifiers

H-1710-067-894

Identifier Type: -

Identifier Source: org_study_id