Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

Cancer of Pancreas Clinical Trial

Official title:

Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03278015
• Other study ID #: XDB-001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 8, 2017
• Last updated: September 8, 2017
• Start date: October 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: September 2017
• Source: Chinese PLA General Hospital
• Contact: Dabin Xu, M.D.
• Phone: 8613522065659
• Email: xdabin[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method clinically. Recently radical surgical resection is recommended for this cancer, How to improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can partly raise post-operative survival rate. the purpose of this study is to three chemotherapy regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with gemcitabine),which is best regimens for raising patients' survival rate, and will provide a chemotherapy choice for clinic therapy of pancreatic cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 30, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Signed informed-consent form.

2. Man or woman aged 18 years to 80 years.

3. Histologically confirmed pancreatic carcinoma, and the histological type is ductal adenocarcinoma.

4. Mild (Child-Pugh A), moderate (Child-Pugh B) and some preferable severe (Child-Pugh C, <=10) hepatic dysfunction according to the Child-Pugh Scoring system criteria.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life expectation of no less than 12 weeks.

6. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) =1.5 x 109/L; platelets = 70 x 109/L; hemoglobin = 8.0 g/dL.

7. Albumin = 30 g/L.

8. Adequate hepatic function as evidenced by Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 5 x upper limit of normal (ULN); Serum total bilirubin = 1.5 x ULN; Serum creatinine = 1.5 x ULN.

9. Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.

10. Willing and able to comply with study procedures for the duration of the study.

Exclusion Criteria:

1. Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg, diastolic pressure >90 mmHg) after treatment.

2. Patients have active cardiac disease including any of the following:

1. In resting state, average correction QTc > 470 msec on mean value of 3 times screening ECGs.

2. Any clinically significant abnormal ECG form, for example, complete left bundle branch block, 3-degree atrioventricular block, 2-degree atrioventricular block, or PR interval > 250 msec.

3. Any factors may increase the risk of QTc prolongation or arrhythmic event.

4. Left ventricular ejection fraction (LVEF) < 50%.

3. Patient weight still in losing period.

4. History of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such as esophageal varices with high risk of bleeding, local active ulcerative lesions, fecal occult blood test>= (+ +) within the past 6 months, shall not enter the trial. If fecal occult blood test (+), the patient is requested for gastroscopy.

5. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within the past 28 days, should not enter the trial.

6. Patients with coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 sec), with bleeding tendency or are treated with thrombolytic or anticoagulant therapy.

7. Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, for example, HBV, HCV, or HIV.

8. Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1.

9. Patients with mental illness, or with psychiatric history of drug abuse.

Related Conditions & MeSH terms

• Cancer of Pancreas
• Pancreatic Neoplasms

Intervention

Drug:
• Nab-paclitaxel plus Gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
• Gemcitabine monotherapy
Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
• S-1 monotherapy
S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival(DFS)	To determine the DFS of post-operative patients with pancreatic cancer	3 years
Primary	overall survival time (OS)	To determine the OS post-operative patients with pancreatic cancer	5 years
Primary	median overall survival time (mOS)	To determine the mOS post-operative patients with pancreatic cancer	5 years
Secondary	Objective Response Rate(ORR)	All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations	3 years
Secondary	Quality of Life Assessment		3 years
Secondary	safety profile	Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups	3 years
Secondary	Disease control rate(DCR)		3 years