Nab-paclitaxel and Gemcitabine in Metastatic Pancreatic Cancer

NCT03929094 | Unknown Phase 2

• 1 other identifier: CSPAC-22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open-label Phase II clinical trial to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients with metastatic pancreatic cancer.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate

  To evaluate the Overall Response Rate of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.

  through study completion, an average of 1 year

• Progression Free Survival

  To evaluate the Progression Free Survival of patients with metastatic pancreatic cancer after treated with nab-paclitaxel plus gemcitabine.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• overall survival

  through study completion, an average of 1 year

• adverse events

  through study completion, an average of 1 year

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: Paclitaxel for Injection（Albumin Bound）; Drug: Gemcitabine

Interventions

Paclitaxel for Injection（Albumin Bound） 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 until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.

Also known as: Paclitaxel

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 until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.

nab-paclitaxel + gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed content obtained prior to treatment. The patients were fully explained and understood the purpose, contents, predicted efficacy, pharmacological effects, and risks of this study.
• target population
• the patients were confirmed as metastatic pancreatic cancer by histopathology or cytopathology.
• At least one measurable objective lesion (both primary and metastatic) was identified based on the RECIST1.1 criteria;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• The expected survival after surgery ≥ 3 months
• The subjects have good compliance, can be treated and followed up, and voluntarily comply with the relevant provisions of this study
• No contraindications for gemcitabine and nab-paclitaxel.
• Age and reproductive status
• Age ≥ 18 years and ≤ 75 years
• Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 24 hours before the start of chemotherapy;
• Women must not lactate.

You may not qualify if:

• The target disease has cerebral metastasis;
• medical history and complications
• patients had uncontrolled serious medical condition that the investigator considered may affect the subject's to receive treatment under the study program, For example, patients with severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
• Dementia, changing of mental state or any mental illness which could hinder understanding or informed consent or fill out questionnaires;
• History of allergy or hypersensitivity to any therapeutic ingredient;
• Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of randomization, excepted well-treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, and ductal carcinoma in situ of the breast after radical resection.
• Previously received systemic therapy for advanced/metastatic pancreatic cancer;
• Subjects who had previously been pathologically diagnosed with squamous cell carcinoma (no organ limitation) and received neoadjuvant/adjuvant therapy with taxa regimen.
• Patients who had Grade 2 or above Peripheral neuropathy.
• Abnormal results of physical examination and laboratory examination
• Absolute neutrophil count (ANC) 90g/L 1.5 × 109/L; Platelets (PLT) 90g/L 100 × 109/L; Hemoglobin (Hgb) \< 90g/L
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) \>2.5 × institutional upper limit of normal (ULN), \>5 × institutional upper limit of normal (ULN) (hepatic metastases); Total bilirubin (TBIL)\>1.5 × ULN;
• Creatinine (CRE)\> 1.5 × ULN
• Prothrombin time (PT) and international normalized ratio (INR) \> 1.5 × ULN. Unless the subject had received anticoagulant treatment
• Human immunodeficiency virus (HIV)- or hepatitis C virus (HCV) positive patients;

Sponsors & Collaborators

• Fudan University: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

FUDAN University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Xian-Jun Yu

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+86 21 64175590; yuxianjun@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: April 26, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)