Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer

Sponsor

Aiping Zhou (Other)

Overall Status

Completed

CT.gov ID

NCT03415802

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.

Condition or Disease	Intervention/Treatment	Phase
Advanced Pancreatic Cancer	Drug: Nab-paclitaxel and S-1	Phase 2

Detailed Description

Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs. 3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the significant increase of grade 3/4 adverse reactions, to some extent, limited its wide application. Therefore, it is necessary to continue to explore effective and safe chemotherapy of advanced pancreatic cancer.

Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan.

We conducted a single arm, prospective, phase II study in our center on the first-line treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the efficacy and safety of the combination regimen.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer: A Pilot Single Arm Phase II Study

Actual Study Start Date :

May 11, 2015

Actual Primary Completion Date :

Jul 11, 2017

Actual Study Completion Date :

Jul 11, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nab-paclitaxel Plus S-1 Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)	Drug: Nab-paclitaxel and S-1 Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w) Other Names: Abraxane,Tegafur, Gimeracil and Oteracil Porassium

Arm

Intervention/Treatment

Experimental: Nab-paclitaxel Plus S-1

Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)

Drug: Nab-paclitaxel and S-1

Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)

Other Names:

Abraxane,Tegafur, Gimeracil and Oteracil Porassium

Outcome Measures

Primary Outcome Measures

Objective response rate（ORR） [6 month]
CR+PR was defined as objective response rate (ORR)

Secondary Outcome Measures

DCR [6 month]
CR+PR+SD was defined as disease control rate (DCR)
PFS [6 month]
From date of randomization until date of first documented PD, date of death
OS [1 year]
From date of randomization until date of death
Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer [1 year]
Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age, years: 18-75
Histologically and cytologically confirmed advanced pancreatic cancer , inresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
Laboratory examination within 14 days before entering the study should meet following requirements: ANC ≥ 1.5 x 10^{9/L; PLT ≥ 100 x 10}9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
Both male and female subjects of potential fertility have to agree effective birth control during the entire study
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