Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

Pancreatic Cancer Clinical Trial

Official title:

Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03779464
• Other study ID #: XHZL-001
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2019
• Source: Wuhan Union Hospital, China
• Contact: Zhenyu lin, MD
• Phone: 86-27-85871982
• Email: whxhlzy[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer

Description:

A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: September 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histological or cytological confirmation of pancreatic adenocarcinoma

• Distant metastatic or unresctable locally advanced diseases

• CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment

• At least one lesion measurable by RECIST v1.1 criteria

• Life expectancy> 3 months

• No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)

• No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)

• Pain must be monitored before inclusion

• 18 years < age < 70

• Performance status: 0-1

• ANC = 1500/mm3, platelets = 100 000/mm3, haemoglobin = 9 g/dL

• ASAT (SGOT), ALAT (SGPT) = 2.5 x ULN or = 5 x ULN if liver metastases found

• Bilirubin = 1.5 x ULN (patients drained by retrograde technique are includable),

• creatinine < 120 µmol/L, or MDRD creatinine clearance > 60 mL/min

• Patient information and signature of informed consent

Exclusion Criteria:

• Concurrent other effective treatment (including radiotherapy)

• Resectable patients

• Allergy history to other drugs in the same class patients with pregnancy or lactation

• Known severe internal medical diseases

• Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia

• Immunocompromised patients, such as HIV positive

• Uncontrollable mental illness

• Other conditions the researchers considered ineligible for the study

Related Conditions & MeSH terms

• Adenocarcinoma
• Gemcitabine
• Nab-paclitaxel
• Pancreatic Cancer
• Pancreatic Neoplasms
• S1

Intervention

Drug:
• S1 or Gemcitabine
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)

Locations

Country	Name	City	State
China	Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (3)

Ueno H, Ioka T, Ikeda M, Ohkawa S, Yanagimoto H, Boku N, Fukutomi A, Sugimori K, Baba H, Yamao K, Shimamura T, Sho M, Kitano M, Cheng AL, Mizumoto K, Chen JS, Furuse J, Funakoshi A, Hatori T, Yamaguchi T, Egawa S, Sato A, Ohashi Y, Okusaka T, Tanaka M. Ra — View Citation

Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Incr — View Citation

Xu Y, Guo X, Fan Y, Wang D, Wu W, Wu L, Liu T, Xu B, Feng Y, Wang Y, Lou W, Zhou Y. Efficacy and safety comparison of nabpaclitaxel plus S-1 and gemcitabine plus S-1 as first-line chemotherapy for metastatic pancreatic cancer. Jpn J Clin Oncol. 2018 Jun 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression-free survival	6 month
Secondary	OS	overall survival	1 year
Secondary	ORR	objective response rate	6 month
Secondary	DCR	CR+PR+SD was defined as disease control rate (DCR)	6 month
Secondary	Safety profile :Adverse events of nab-Paclitaxel plus S-1	Adverse events of nab-Paclitaxel plus S-1	1 year