NCT03401827

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2018-01-17
• Last updated: 2018-02-12

Locations

1 site across 1 country: South Korea