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

Pancreatic Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03401827
• Other study ID #: H-1710-067-894
• Status: Recruiting
• Phase: Phase 4
• First received: December 30, 2017
• Last updated: February 8, 2018
• Start date: March 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: January 2018
• Source: Seoul National University Hospital
• Contact: Jin Ho Choi, MD
• Phone: 82-2-2072-2228
• Email: pseudo.jh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Chemotherapy Effect
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	survival rate at 6 months after 2nd line chemotherapy	6 months
Secondary	overall survival	overall survival after 2nd line chemotherapy	till death or follow-up loss or end of study up to 2 years
Secondary	Progression free survival	duration till progression after 2nd line chemotherapy	till death or follow-up loss or end of study up to 2 years
Secondary	Disease control rate	SD (stable disease) + PR (partial response) + CR (complete response) after 2nd line chemotherapy	6 months
Secondary	adverse event	all reported adverse events after 2nd line chemotherapy	till death or follow-up loss or end of study up to 2 years