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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
Sponsor:
Collaborators:
Translational Genomics Research Institute
Honor Health - Clinical Trials
Cancer Research and Biostatistics Clinical Trials Consortium
Information provided by (Responsible Party):
Gayle Jameson, Pancreatic Cancer Research Team

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stage IV Pancreatic Cancer
Interventions Drug: nab-paclitaxel
Drug: Cisplatin
Drug: gemcitabine
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nab-Paclitaxel+Cisplatin+Gemcitabine
Hide Arm/Group Description

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.

Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle

Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Nab-Paclitaxel+Cisplatin+Gemcitabine
Hide Arm/Group Description

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.

Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle

Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  48.0%
>=65 years
13
  52.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
64.4  (7.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
11
  44.0%
Male
14
  56.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
1
   4.0%
Not Hispanic or Latino
24
  96.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
24
  96.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
CA19-9 Status at Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Abnormal
19
  76.0%
Normal
6
  24.0%
CEA Status at Baseline (if CA19-9 Normal at Baseline)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Abnormal
2
  50.0%
Normal
2
  50.0%
[1]
Measure Analysis Population Description: Of the 6 patients with normal CA19-9 level at baseline, 4 (66.7%) had baseline CEA data available.
CA125 Status at Baseline (if CA19-9 Normal at Baseline)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Abnormal
2
  50.0%
Normal
2
  50.0%
[1]
Measure Analysis Population Description: Of the 6 patients with normal CA19-9 level at baseline, 4 (66.7%) had baseline CA125 data available.
1.Primary Outcome
Title Complete Response Rate
Hide Description

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.

Time Frame 1 yr.
Hide Outcome Measure Data
Hide Analysis Population Description
Best Response on study was assessed for patients with at least one evaluation for response while evaluable during the study. One patient achieved CR 32 days after the last dose on therapy and had a best response of PR prior to this assessment. The patient is identified as having a best response of CR in this table.
Arm/Group Title Nab-Paclitaxel+Cisplatin+Gemcitabine
Hide Arm/Group Description:

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.

Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle

Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
CR
2
   8.3%
PR
15
  62.5%
SD
4
  16.7%
PD
3
  12.5%
N/A
0
   0.0%
2.Secondary Outcome
Title Treatment-Related Toxicities
Hide Description Frequency of treatment-related toxicities
Time Frame Over the course of the subjects' treatment on study, approx 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients on study were evaluated for maximum grade of treatment-related toxicity.
Arm/Group Title Nab-Pac+Cis+Gem
Hide Arm/Group Description:
Nab-Paclitaxel+Cisplatin+Gemcitabine
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Grade 3 Treatment-Related Adverse Event
12
  48.0%
Maximum Grade 4 Treatment-Related Adverse Event
9
  36.0%
Maximum Grade 5 Treatment-Related Adverse Event
1
   4.0%
No Grade 3-5 Treatment-Related Adverse Event
3
  12.0%
3.Secondary Outcome
Title Percentage Change in CA 19-9
Hide Description Percentage change in CA 19-9 from baseline values
Time Frame Over the course of the subjects' treatment on study, approx 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with a non-zero CA 19-9 measurement at baseline and at least one CA 19-9 measurement on-study were evaluated for percentage change of CA19-9. Of the 25 patients on study, 22 met the criteria for analysis (one had baseline CA 19-9 of zero; two had no post-baseline CA 19-9 measurements).
Arm/Group Title Nab-Pac+Cis+Gem
Hide Arm/Group Description:
Nab-Paclitaxel+Cisplatin+Gemcitabine
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: percentage change CA 19-9 from baseline
-47.7  (77.13)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from study enrollment until death from any cause.
Time Frame Over the course of the subjects' treatment and participation in study, approx 18 mos
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were evaluated for overall survival.
Arm/Group Title Nab-Pac+Cis+Gem
Hide Arm/Group Description:

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.

Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle

Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
16.4
(10.2 to 25.3)
5.Secondary Outcome
Title Progression-Free Survival
Hide Description 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.
Time Frame Over the course of the subjects' treatment and participation in study, approx 18 mos
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were evaluated for progression-free survival.
Arm/Group Title Nab-Pac+Cis+Gem
Hide Arm/Group Description:

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.

Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle

Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
10.1
(6.0 to 12.5)
Time Frame Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later.
Adverse Event Reporting Description The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
 
Arm/Group Title Nab-Paclitaxel+Cisplatin+Gemcitabine
Hide Arm/Group Description

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.

Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle

Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

All-Cause Mortality
Nab-Paclitaxel+Cisplatin+Gemcitabine
Affected / at Risk (%)
Total   21/25 (84.00%) 
Hide Serious Adverse Events
Nab-Paclitaxel+Cisplatin+Gemcitabine
Affected / at Risk (%)
Total   12/25 (48.00%) 
Blood and lymphatic system disorders   
Anemia   1/25 (4.00%) 
Febrile neutropenia   1/25 (4.00%) 
Cardiac disorders   
Cardiac arrest   1/25 (4.00%) 
Gastrointestinal disorders   
Diarrhea   1/25 (4.00%) 
Nausea   1/25 (4.00%) 
Vomiting   1/25 (4.00%) 
General disorders   
Fever   2/25 (8.00%) 
Infections and infestations   
Acute cryptosporidiosis   1/25 (4.00%) 
Lung infection   1/25 (4.00%) 
Sepsis   1/25 (4.00%) 
Investigations   
Platelet count decreased   2/25 (8.00%) 
Metabolism and nutrition disorders   
Dehydration   2/25 (8.00%) 
Nervous system disorders   
Stroke   2/25 (8.00%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis   1/25 (4.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nab-Paclitaxel+Cisplatin+Gemcitabine
Affected / at Risk (%)
Total   24/25 (96.00%) 
Blood and lymphatic system disorders   
Anemia   7/25 (28.00%) 
Gastrointestinal disorders   
Diarrhea   3/25 (12.00%) 
Nausea   1/25 (4.00%) 
Vomiting   1/25 (4.00%) 
General disorders   
Fatigue   1/25 (4.00%) 
Infections and infestations   
Lung infection   1/25 (4.00%) 
Anorectal infection   1/25 (4.00%) 
Enterocolitis infectious   1/25 (4.00%) 
Investigations   
Platelet count decreased   18/25 (72.00%) 
Neutrophil count decreased   6/25 (24.00%) 
White blood cell decreased   2/25 (8.00%) 
Lymphocyte count decreased   1/25 (4.00%) 
Lymphocyte count increased   1/25 (4.00%) 
Metabolism and nutrition disorders   
Hyperglycemia   2/25 (8.00%) 
Hypokalemia   2/25 (8.00%) 
Hyponatremia   2/25 (8.00%) 
Hypophosphatemia   1/25 (4.00%) 
Nervous system disorders   
Peripheral motor neuropathy   1/25 (4.00%) 
Vascular disorders   
Thromboembolic event   1/25 (4.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adam Rosenthal
Organization: Cancer Research and Biostatistics
Phone: (206) 839-1797
EMail: adamr@crab.org
Layout table for additonal information
Responsible Party: Gayle Jameson, Pancreatic Cancer Research Team
ClinicalTrials.gov Identifier: NCT01893801    
Other Study ID Numbers: PCRT 12-001
First Submitted: July 2, 2013
First Posted: July 9, 2013
Results First Submitted: March 28, 2019
Results First Posted: May 29, 2019
Last Update Posted: May 29, 2019