Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

NCT ID: NCT02023021

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-01-31

Brief Summary

Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than 5%. About 25% of patients have the opportunity for radically surgical resection when diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and enhanced overall survival for patients who have undergone surgery to remove their tumor. Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival and overall survival of metastatic pancreatic cancer patients. The present study is intended to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel as adjuvant chemotherapy in treating patients with pancreatic cancer after curative resection.

Conditions

Stage IA Pancreatic Adenocarcinoma; Stage IB Pancreatic Adenocarcinoma; Stage IIA Pancreatic Adenocarcinoma; Stage IIB Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nab-paclitaxel + gemcitabine

nab-paclitaxel at 100 mg/m\^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m\^2 on days 1, 8, and 15

Group Type: EXPERIMENTAL

nab-paclitaxel

Intervention Type: DRUG

Patients firstly receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

gemcitabine

Intervention Type: DRUG

Patients secondly receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Interventions

nab-paclitaxel

Patients firstly receive nab-paclitaxel 100 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Intervention Type: DRUG

gemcitabine

Patients secondly receive gemcitabine 1000 mg/m\^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Abraxane; GEMZAR

Eligibility Criteria

Inclusion Criteria

• Signed informed content obtained prior to treatment
• Age ≥ 18 years and ≤ 75 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant) after curative resection (R0). The pathological staging does not exceed the stage IIB.
• No tumor lesions are seen by abdominal and thoracic CT scan 4~8 weeks after surgery, and no serious adverse events are occurred during this period
• The expected survival after surgery ≥ 6 months
• White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb) ≥ 9 g/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
• Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN

Exclusion Criteria

• Active second primary malignancy or history of second primary malignancy within the last 3 years
• Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
• Use of any other investigational agents
• Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, internal hemorrhage, pancreatic leakage, bile leakage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• History of allergic reactions attributed to compounds of similar chemical or biological composition to nab-paclitaxel or gemcitabine
• Metabolic acidosis, acute or chronic, including ketoacidosis
• Pregnant or nursing women
• Human immunodeficiency virus (HIV)-positive patients
• Patients who are unwilling or unable to comply with study procedures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xian-Jun Yu

OTHER

Sponsor Role: lead

Responsible Party

Xian-Jun Yu

M.D., Ph.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xian-Jun Yu, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China.

Locations

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China

Shanghai, , China

Countries

China

Other Identifiers

ABX-1312129-8

Identifier Type: -

Identifier Source: org_study_id