Back to resultsNab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
Primary Purpose
Stage IA Pancreatic Adenocarcinoma, Stage IB Pancreatic Adenocarcinoma, Stage IIA Pancreatic Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
nab-paclitaxel
gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Stage IA Pancreatic Adenocarcinoma focused on measuring Pancreatic Cancer; Pancreatic Adenocarcinoma; Nab-paclitaxel; Gemcitabine; Adjuvant Therapy
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
Sites / Locations
- Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nab-paclitaxel + gemcitabine
Arm Description
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
Outcomes
Primary Outcome Measures
Recurrence-free survival at one year after curative resection
To evaluate the therapeutic efficacy of nab-paclitaxel plus gemcitabine chemotherapy in terms of recurrence-free survival in patients with pancreatic cancer at one year after curative resection. Computed tomography (CT) scan
Secondary Outcome Measures
Overall survival after curative resection
To evaluate the overall survival of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
Quality of life score after curative resection
To evaluate the quality of life score of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0
To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; version 4.0) in patients treated with this regimen. The toxicity profile includes but not limits neutropenia, thrombocytopenia, peripheral neuropathy, hypoglycemia, metabolic acidosis (acute or chronic, including ketoacidosis), which will be summarized as the percentage of patients by type and grade according to treatment group. Outpatient visit, laboratory findings
CA199 level after curative resection
To evaluate the CA199 level of patients (after curative resection) treated with this regimen. Outpatient visit, laboratory findings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02023021
Brief Title
Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
Official Title
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Pancreatic Cancer After Curative Resection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xian-Jun Yu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IA Pancreatic Adenocarcinoma, Stage IB Pancreatic Adenocarcinoma, Stage IIA Pancreatic Adenocarcinoma, Stage IIB Pancreatic Adenocarcinoma
Keywords
Pancreatic Cancer; Pancreatic Adenocarcinoma; Nab-paclitaxel; Gemcitabine; Adjuvant Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nab-paclitaxel + gemcitabine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
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
Intervention Name(s)
gemcitabine
Other Intervention Name(s)
GEMZAR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence-free survival at one year after curative resection
Description
To evaluate the therapeutic efficacy of nab-paclitaxel plus gemcitabine chemotherapy in terms of recurrence-free survival in patients with pancreatic cancer at one year after curative resection. Computed tomography (CT) scan
Time Frame
From date of enrollment (after curative resection) until the date of first documented recurrence or date of death from any cause, whichever came first, assessed 2 months during therapy and 3 months thereafter up to 24 months
Secondary Outcome Measure Information:
Title
Overall survival after curative resection
Description
To evaluate the overall survival of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
Time Frame
From date of enrollment (after curative resection) until the date of death from any cause, assessed one month during therapy and 3 months thereafter up to 24 months
Title
Quality of life score after curative resection
Description
To evaluate the quality of life score of patients (after curative resection) treated with this regimen. Outpatient visit, phone interview
Time Frame
One month during therapy and 3 months thereafter up to 24 months
Title
Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0
Description
To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; version 4.0) in patients treated with this regimen. The toxicity profile includes but not limits neutropenia, thrombocytopenia, peripheral neuropathy, hypoglycemia, metabolic acidosis (acute or chronic, including ketoacidosis), which will be summarized as the percentage of patients by type and grade according to treatment group. Outpatient visit, laboratory findings
Time Frame
One week during therapy and 3 months thereafter up to 24 months
Title
CA199 level after curative resection
Description
To evaluate the CA199 level of patients (after curative resection) treated with this regimen. Outpatient visit, laboratory findings
Time Frame
One month during therapy and 3 months thereafter up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Jun Yu, M.D., Ph.D.
Organizational Affiliation
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Shanghai Pancreatic Cancer Institute; Pancreatic Cancer Institute, Fudan University. Shanghai, China
City
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
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Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
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