Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection

NCT02506842 | Unknown Phase 3 DMC

• 1 other identifier: CSPAC-010
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to investigate the activity and safety of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.

Conditions

Stage ⅠA Pancreatic Cancer; Stage ⅠB Pancreatic Cancer; Stage ⅡA Pancreatic Cancer; Stage ⅡB Pancreatic Cancer

Keywords

Pancreatic Cancer; Pancreatic Adenocarcinoma; AG; OFF; Second-Line Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival

  To evaluate the therapeutic efficacy of second-line adjuvant therapy with AG versus OFF in terms of overall survival for gemcitabine-refractory pancreatic cancer after curative resection. Outpatient visit, phone interview

  From date of enrollment until the date of death from any cause, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).

Secondary Outcomes (6)

• Objective Response Rate

  Complete Remission% + Partial Remission %, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).

• Time to Remission

  From date of enrollment until the date of remission, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).

• Progression-Free Survival

  From date of enrollment until the date of first documented progression, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).

• The Levels of Tumor Biomarkers in Serum

  2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).

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

  1 week during therapy and 3 months thereafter up to 24 months.

Study Arms (2)

nab-paclitaxel + gemcitabine (AG)

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

oxaliplatin + folinic acid + fluorouracil (OFF)

EXPERIMENTAL

oxaliplatin at 85mg/m\^2 on days 8 and 22, folinic acid at 200mg/m\^2 on days 1,8,15 and 22, fluorouracil at 2000mg/m\^2 on days 1,8,15 and 22.

Drug: oxaliplatin; Drug: folinic acid; Drug: fluorouracil

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 until there is disease progression or recurrence.

Also known as: Abraxane

nab-paclitaxel + gemcitabine (AG)

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 until there is disease progression or recurrence.

Also known as: GEMZAR

nab-paclitaxel + gemcitabine (AG)

oxaliplatin DRUG

Patients receive oxaliplatin 85 mg/m\^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle. Treatment repeats until there is disease progression or recurrence. Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days.

oxaliplatin + folinic acid + fluorouracil (OFF)

folinic acid DRUG

Patients receive folinic acid 200 mg/m\^2 (iv) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.

Also known as: LV

oxaliplatin + folinic acid + fluorouracil (OFF)

fluorouracil DRUG

Patients receive fluorouracil 2000 mg/m\^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.

oxaliplatin + folinic acid + fluorouracil (OFF)

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 R0 or R1 resection. The pathological staging does not exceed the stage ⅡB. And the patients have received gemcitabine as adjuvant chemotherapy after curative resection.
• There is progression or recurrence of tumor during the course of adjuvant chemotherapy with gemcitabine, or within 6 months after the whole courses of treatment.
• No severe defects in hematological system, immune system, cardiac function and pulmonary function.
• White blood cell (WBC) ≥ 4 × 10\^9/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelets (PLT) ≥ 100 × 10\^9/L; Hemoglobin (Hgb) ≥ 9 g/dL
• Aspartate aminotransferase (AST) (serum glutamate oxaloacetate transaminase (SGOT)）/ alanine aminotransferase (ALT) (serum glutamate 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
• The patients are willing to comply to the study plan and other requirements.

You may not qualify if:

• There is another malignant tumor with the patient.
• Patients who have received any form of anti-tumor therapy within 4 weeks prior to the enrollment, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
• Use of any other investigational agents within 4 weeks prior to the enrollment.
• The progression or recurrence of tumor occurs after 6 months of the course of the adjuvant chemotherapy with gemcitabine.
• 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 the drugs.
• Metabolic acidosis, acute or chronic, including ketoacidosis
• Pregnant or nursing women
• Any event or condition that is possible to harm the safety of the patients or the integrities of data, including severe medical risk factors, medical conditions, and laboratory disorders.
• Patients who are unwilling or unable to comply with study procedures, or may be absent from the observation for more than 7 days.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (7)

Department of Hepatobiliary Surgery, Sun Yat-Sen University Cancer Center,Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Department of Biliary Pancreatic Surgery, Shanghai Changzheng Hospital, The Second Military Medical University

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Department of Biliary Pancreatic Surgery, Huadong Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Department of Pancreatic Surgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Department of Pancreatic Surgery, Cancer Institute & Hospital, Tianjin Medical University

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Department of General Surgery,Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Oxaliplatin; Leucovorin; Fluorouracil

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; Coordination Complexes; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones

Study Officials

• Xian-Jun Yu, M.D PH.D

  Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xian-Jun Yu, M.D PH.D

CONTACT

+86 21 64175590; yuxianjun@fudanpci.org

Wen-Quan Wang, M.D PH.D

CONTACT

+86 21 64175590; wangwenquan@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D PH.D

Study Record Dates

• First Submitted: July 18, 2015
• First Posted: July 23, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

CN (7)