Nab-Paclitaxel+Cisplatin+Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
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|ClinicalTrials.gov Identifier: NCT01893801|
Recruitment Status : Unknown
Verified February 2014 by Gayle Jameson, Pancreatic Cancer Research Team.
Recruitment status was: Recruiting
First Posted : July 9, 2013
Last Update Posted : March 3, 2014
|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 Multiple cycles may be administered until the patient is withdrawn from therapy.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)|
|Estimated 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|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||August 2014|
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
- 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.
- Evaluate disease control rate [ Time Frame: 9 weeks ]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 ]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 ]Evaluate the change in CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) in this patient population.
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
|Contact: Amy Stoll-D'Astice, MS, CCRP||(602) firstname.lastname@example.org|
|United States, Arizona|
|Scottsdale Health Care||Recruiting|
|Scottsdale, Arizona, United States, 85260|
|Contact: Joyce Schaffer, MSN RN AOCNS 480-323-1339 email@example.com|
|Principal Investigator: Gayle S Jameson, MSN ACNP-BC|
|Sub-Investigator: Ramesh K Ramanathan, MD|
|Sub-Investigator: Daniel D Von Hoff, MD FACP|
|Sub-Investigator: Katy B Schroeder, RN BSN OCN|
|United States, New Jersey|
|Rutgers - Cancer Institute of New Jersey (CINJ)||Recruiting|
|New Brunswick, New Jersey, United States, 08901|
|Contact: Anjali Krishnan, RN 732-235-8996 firstname.lastname@example.org|
|Contact: Tatianna Zelinskaya 732-235-9837 email@example.com|
|Principal Investigator: Elizabeth Popllin, MD|
|United States, Pennsylvania|
|Vita Medical Associates, PC||Recruiting|
|Bethlehem, Pennsylvania, United States, 18015|
|Contact: Colleen Saitta, NP 610-866-0113 firstname.lastname@example.org|
|Contact: Gulyun Zhou, NP 610-866-0113 email@example.com|
|Principal Investigator: Anna A Niewiarowska, MD|
|Principal Investigator:||Gayle S Jameson, MSN ACNP-BC||Scottsdale Health Care|