Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT03915444|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Ductal Adenocarcinoma||Drug: nab-Paclitaxel + Cisplatin + Gemcitabine||Phase 2|
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 Multiple cycles may be administered until the patient is withdrawn from therapy.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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||April 15, 2021|
|Estimated Study Completion Date :||April 15, 2022|
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
Drug: nab-Paclitaxel + Cisplatin + Gemcitabine
Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days.
Gemcitabine 1000mg/m2 in 500 mL* over 30 minute IV infusion on days 1 and 8 repeated every 21 days.
Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days.
Other Name: NabCG
- 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
- Change in tumor markers [ Time Frame: 63 days ]To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 9 weeks) of the combination of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with stage IV metastatic pancreatic cancer.complete response rate( RECIST 1.1), disease control rate at 9 weeks, Change and rates of normalization in CA 19-9 (or Ca125 or CEA if not expressers of CA 19-9)
- Quality of Life: MD Anderson Symptom Inventory (MDASI-GI) [ Time Frame: 63 days ]Changes in patient's self-reported quality of life will be determined by administering the MD Anderson Symptom Inventory (MDASI-GI). This questionnaire asks about severity of symptoms using numbers (0 = not present to 10 = as bad as you can imagine).
- Pain Control: Brief Pain Inventory (BPI) [ Time Frame: 63 days ]Changes in patient's self-reported pain levels will be determined by administering the Brief Pain Inventory (BPI). This form asks about severity of pain using numbers (0 = not present to 10 = as bad as you can imagine).
- Potential tumor biomarkers [ Time Frame: 63 days ]Tumor biopsy testing will be completed to evaluate potential biomarkers in the tumor to evaluate various copy number variant signatures
- Disease Response [ Time Frame: 63 days ]Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915444
|Contact: Joyce Schafferemail@example.com|
|United States, Arizona|
|HonorHealth Research Institute||Recruiting|
|Scottsdale, Arizona, United States, 85258|
|Contact: Joyce Schaffer, MSN, AOCNS|
|Principal Investigator: Gayle S Jameson, MSN, ACNP-BC, AOCN|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Peter Hosein, MD mailto:firstname.lastname@example.org|
|United States, Louisiana|
|Ochsner Clinic Foundation||Recruiting|
|New Orleans, Louisiana, United States, 70121|
|Contact: Erin Pierce, NP email@example.com|
|United States, Wisconsin|
|Froedtert & Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Mandana Kamgar, MD firstname.lastname@example.org|
|Principal Investigator:||Gayle Jameson, ACNP-BC||HonorHealth Research Institute|