Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA
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|ClinicalTrials.gov Identifier: NCT01893801|
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : May 29, 2019
Last Update Posted : May 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Pancreatic Cancer||Drug: nab-paclitaxel Drug: Cisplatin Drug: gemcitabine||Phase 1 Phase 2|
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 Multiple cycles may be administered until the patient is withdrawn from therapy.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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||October 1, 2017|
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: Abraxane
25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle
1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Other Name: Gemzar
- Complete Response Rate [ Time Frame: 1 yr. ]
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.
- Treatment-Related Toxicities [ Time Frame: Over the course of the subjects' treatment on study, approx 1 year ]Frequency of treatment-related toxicities
- Percentage Change in CA 19-9 [ Time Frame: Over the course of the subjects' treatment on study, approx 1 year ]Percentage change in CA 19-9 from baseline values
- Overall Survival [ Time Frame: Over the course of the subjects' treatment and participation in study, approx 18 mos ]Overall survival is defined as the time from study enrollment until death from any cause.
- Progression-Free Survival [ Time Frame: Over the course of the subjects' treatment and participation in study, approx 18 mos ]Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause.
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): 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|