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

NCT02023021 | Completed Phase 2 DMC

• 1 other identifier: ABX-1312129-8
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Pancreatic Cancer; Pancreatic Adenocarcinoma; Nab-paclitaxel; Gemcitabine; Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (4)

• Overall survival after curative resection

  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

• Quality of life score after curative resection

  One month during therapy and 3 months thereafter up to 24 months

• Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0

  One week during therapy and 3 months thereafter up to 24 months

• CA199 level after curative resection

  One month during therapy and 3 months thereafter up to 24 months

Study Arms (1)

nab-paclitaxel + gemcitabine

EXPERIMENTAL

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

Drug: nab-paclitaxel; Drug: gemcitabine

Interventions

nab-paclitaxel 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.

Also known as: Abraxane

nab-paclitaxel + gemcitabine

gemcitabine 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.

Also known as: GEMZAR

nab-paclitaxel + gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Jun Yu: lead

Study Sites (1)

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

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xian-Jun Yu, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

CN (1)