Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma
PrE0204
A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma
3 other identifiers
interventional
74
2 countries
25
Brief Summary
Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2014
Typical duration for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 4, 2014
CompletedStudy Start
First participant enrolled
December 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedResults Posted
Study results publicly available
May 29, 2018
CompletedOctober 3, 2018
September 1, 2018
1.8 years
July 2, 2014
April 26, 2018
September 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)
Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions.
Assessed at 6 months
Secondary Outcomes (7)
Overall Survival (OS)
Every 3-6 months for up to 3 years
Progression-free Survival (PFS)
Every 3-6 months for up to 3 years
Time To Progression (TTP)
Every 3-6 months for up to 3 years
Overall Response Rate (ORR)
Every 3-6 months for up to 3 years
Disease Control Rate (DCR)
Every 3-6 months for up to 3 years
- +2 more secondary outcomes
Other Outcomes (6)
Change in Circulating Tumor Cells (CTCs)
Prior to Cycle 1, Day 1; Cycle 1 Day 8; Cycle 3, Day 1 and at Off Treatment
Stromal SPARC Expression
Baseline
Fibrosis Expression
Baseline
- +3 more other outcomes
Study Arms (1)
Nab-Paclitaxel and Gemcitabine
EXPERIMENTALNab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.
Interventions
Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes.
Eligibility Criteria
You may qualify if:
- Must have histologically-confirmed diagnosis of cholangiocarcinoma Stage II, III, or IV CCA (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed histology are not allowed.
- Must have radiographically measurable disease in at least one site not previously treated with radiation, chemoembolization, radioembolization, or other local ablative procedures; a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a Radiologist, is acceptable.
- May have received prior radiation, chemoembolization, radioembolization, or other local ablative therapies, or hepatic resection if completed ≥ 4 weeks prior to registration AND if patient has recovered to ≤ grade 1 toxicity. NOTE: Measurable disease (as required above) must still be present.
- May have received prior radiation for bone or brain metastases if patient is now asymptomatic and has completed all radiation and steroid therapy (if applicable) ≥ 2 weeks prior to registration.
- Age ≥ 18 years.
- Child-Pugh score of A or B with ≤ 7 points.
- Eastern Cooperative Oncology Group performance status of 0-1.
- Willing to provide archived tissue, if available, from a previous diagnostic biopsy.
- Must be able to tolerate CT and/or MRI with contrast.
- Adequate organ function obtained ≤ 2 weeks prior to registration:
- Absolute Neutrophil Count ≥ 1500/mm³
- Hemoglobin ˃9.0 g/dL
- Platelets ˃100,000/mm³
- Serum Creatinine ≤ 1.5x Upper Limit Normal (ULN)
- Creatinine Clearance ≥ 50 mL/min
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PrECOG, LLC.lead
- Celgene Corporationcollaborator
Study Sites (25)
Colorado Cancer Research Program
Denver, Colorado, 80222, United States
Northwestern University
Chicago, Illinois, 60611, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, 51101, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
St. Joseph Mercy Health System
Ann Arbor, Michigan, 48106-0995, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48109, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, 55416, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Mount Sinai Hospital
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
University of Pennsylvania, Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania; Abramson Cancer Center at Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
Aurora Cancer Care
Wauwatosa, Wisconsin, 53226, United States
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (1)
Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. Nab-Paclitaxel and Gemcitabine as First-line Treatment of Advanced or Metastatic Cholangiocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. doi: 10.1001/jamaoncol.2018.3277.
PMID: 30178032RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- PrECOG Statistician
- Organization
- ECOG-ACRIN Biostatistics Center
Study Officials
- STUDY CHAIR
Vaibhav Sahai, MD
University of Michigan Health System in Ann Arbor, MI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 4, 2014
Study Start
December 9, 2014
Primary Completion
September 24, 2016
Study Completion
October 1, 2017
Last Updated
October 3, 2018
Results First Posted
May 29, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share
Data is proprietary