Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01661114 · ClinicalTrials.gov registry record · Phase 2
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
A Phase 2 study of Pancreatic Cancer and Biliary Cancer, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT01661114 is a Phase 2 study of Pancreatic Cancer and Biliary Cancer that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 39 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01661114, a Phase 2 study of Pancreatic Cancer and Biliary Cancer, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers leading to responses in a substantial minority and increasing survival. The use of the FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical experience within the University of Michigan Pancreatic Program leads to an expectation of tolerance and efficacy of the proposed regimen. Advantages of the proposed regimen relative to FOLFIRINOX include: 1. Substitution of gemcitabine for irinotecan. Single agent activity of gemcitabine is at least as good as irinotecan (probably better, especially when delivered by FDR \[fixed-dose rate\] infusion) and gemcitabine is much better tolerated with less diarrhea, nausea/emesis, myelosuppression and alopecia. 2. Deletion of leucovorin infusion and 5FU bolus injection will lessen myelosuppression, mucositis and diarrhea. 3. Substitution of cisplatin for oxaliplatin will reduce cost of therapy and avoid cold aggravated dysesthesia. Presuming evidence of efficacy and confirmation of tolerance with the proposed regimen, the investigators believe this treatment may be more widely applicable to pancreatic-biliary cancer patients, including those with advanced disease as well as being considered for use in locally advanced and neo- and adjuvant settings.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG 5-FU
Study Locations (1)
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01661114
The ClinicalTrials.gov registry entry for NCT01661114 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (90% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT01661114 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT01661114 about?
NCT01661114 is a clinical study titled "A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers". Multi-agent chemotherapy has value for patients with advanced pancreatic-biliary cancers leading to responses in a substantial minority and increasing survival. The use of the FOLFIRINOX regimen is limited by its' intensity and toxicity. Previous protocol and clinical experience within the Universit...
What is the current status of trial NCT01661114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2011-07. Estimated completion is 2016-03.
What conditions does trial NCT01661114 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Biliary Cancer.
What interventions are being tested in trial NCT01661114?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), 5-FU (DRUG).
Who is sponsoring clinical trial NCT01661114?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01661114 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pancreatic Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
RECRUITING · Phase 2
-
Pancreatic Cancer Adaptive Neoadjuvant Chemotherapy Trial
RECRUITING · Phase 2
-
Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer
RECRUITING · Phase 2
-
Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer
RECRUITING · Phase 2
-
PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples
RECRUITING · Phase 2
-
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.