Nab-Paclitaxel+Cisplatin+Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
Recruitment status was: Recruiting
Stage IV Pancreatic Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)|
- Complete Response Rate [ Time Frame: 1 yr. ] [ Designated as safety issue: No ]
The primary objectives of this study is to pursue treatment of 25 individual patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDA) to evaluate:
Complete response rate as defined by computed tomography (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). We expect to accomplish this in > or = to 5% of patients. When a complete response (CR) is documented, a confirmatory PET scan will be obtained.
If 1 or more of 10 patients demonstrate a complete response (CR), study will continue to enroll to a total of 25 patients.
If intolerable adverse events or no clinical benefit are noted in the first 6 patients, study will discontinue enrollment.
- Evaluate disease control rate [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]Evaluate disease control rate (CR, PR and SD at 9 weeks) in patients with metastatic PDA.
- Evaluate treatment-related toxicities [ Time Frame: Over the course of the study ] [ Designated as safety issue: Yes ]Evaluate the treatment-related toxicities in this patient population.
- Evaluate the change in CA 19-9 or other biomarkers [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]Evaluate the change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) in this patient population.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
This is a phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel 125mb/m2, cisplatin 25mg/m2, and gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.
25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Other Name: AbraxaneDrug: Cisplatin
25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle
Other Names:Drug: gemcitabine
1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Other Name: Gemzar
This is a phase 1b/2 open-label pilot study evaluating the preliminary 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 (complete response-CR, partial response-PR, stable disease-SD and progressive disease-PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression free survival (PFS) and OS (overall survival) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE (v4.0, May 2009).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893801
|United States, Arizona|
|Scottsdale Health Care|
|Scottsdale, Arizona, United States, 85260|
|United States, New Jersey|
|Rutgers - Cancer Institute of New Jersey (CINJ)|
|New Brunswick, New Jersey, United States, 08901|
|United States, Pennsylvania|
|Vita Medical Associates, PC|
|Bethlehem, Pennsylvania, United States, 18015|
|Principal Investigator:||Gayle S Jameson, MSN ACNP-BC||Scottsdale Health Care|