A Phase II Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- nab-Paclitaxel + Cisplatin + Gemcitabine
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Sponsor
- HonorHealth Research Institute
- Enrollment
- 42
- Locations
- 4
- Primary Endpoint
- 12- Month Overall Survival
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.
Detailed Description
This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy. Overall response rates as well as individual categories of response (CR, PR, SD, and PD) will be determined using RECIST 1.1 (Frese 2012). Time-to-event endpoints, including PFS and OS will be assessed using the Kaplan-Meier method (Kaplan 1958). Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 5.0.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years of age; male or female
- •Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
- •Capable of providing informed consent and complying with trial procedures.
- •Karnofsky Performance Status (KPS) of ≥ 70%.
- •Life expectancy ≥ 12 weeks.
- •Measurable tumor lesions according to RECIST 1.1 criteria.
- •\< Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
- •Patient has acceptable coagulation status as indicated by an INR ≤1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
- •Patients must have normal organ and marrow function as defined below:
- •Absolute neutrophil count ≥1,500/mm3
Exclusion Criteria
- •Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the neoadjuvant and/or adjuvant setting with gemcitabine and/or 5-FU based therapies or gemcitabine and/or 5FU administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- •Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
- •Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
- •Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
- •History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
- •Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
- •History of HIV infection.
- •Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
- •Major surgery within 4 weeks prior to initiation of study treatment.
- •Any condition in the opinion of the principal investigator that might interfere with the patient's participation in the study or in the evaluation of the study results.
Arms & Interventions
NabCG
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
Intervention: nab-Paclitaxel + Cisplatin + Gemcitabine
Outcomes
Primary Outcomes
12- Month Overall Survival
Time Frame: 360 days
Evaluate the 12-month OS rate in patients with metastatic PDA treated with nab-paclitaxel plus cisplatin plus gemcitabine
Secondary Outcomes
- Pain Control: Brief Pain Inventory (BPI)(63 days)
- Change in tumor markers(63 days)
- Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)(63 days)
- Potential tumor biomarkers(63 days)
- Disease Response(63 days)