Trial · NCT01661114
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
NCT01661114, Phase 2, Completed, University of Michigan Rogel Cancer Center; results first posted 2016-02-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers. Trials, record NCT01661114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01661114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
- NCT number
- NCT01661114
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Conditions
- Pancreatic Cancer, Biliary Cancer
- Interventions
- Gemcitabine, 5-FU, Cisplatin
- First posted
- 2012-08-09
- Last updated
- 2016-10-19
- Results first posted
- 2016-02-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment | 28 days | The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients. Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Median Overall Survival of Previously Treated and Previously Untreated Patients | 1 year | To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment | 28 days | Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease. | percentage of patients | NUMBER |
| SECONDARY | Median Overall Survival of Previously Treated and Previously Untreated Patients | 1 year | Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment | Gemcitabine, 5-FU and Cisplatin | Untreated | 40 | 95% Confidence Interval 21.1 to 61.3 | percentage of patients |
| The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment | Gemcitabine, 5-FU and Cisplatin | Received Previous Treatment | 7.1 | 95% Confidence Interval 1.8 to 33.9 | percentage of patients |
| Median Overall Survival of Previously Treated and Previously Untreated Patients | Gemcitabine, 5-FU and Cisplatin | Previously Untreated | 10.3 | 95% Confidence Interval 8 to 19.4 | Months |
| Median Overall Survival of Previously Treated and Previously Untreated Patients | Gemcitabine, 5-FU and Cisplatin | Previously Treated | 4.9 | 95% Confidence Interval 3.6 to 11.9 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine, 5-FU and Cisplatin | 39 | |
| Overall Study | COMPLETED | Gemcitabine, 5-FU and Cisplatin | 39 | |
| Overall Study | NOT COMPLETED | Gemcitabine, 5-FU and Cisplatin | 0 |
Source ClinicalTrials.gov
Adverse events135
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Gemcitabine, 5-FU and Cisplatin | 36 | 39 | 49 |
| other | Palpitations | Cardiac disorders | Gemcitabine, 5-FU and Cisplatin | 1 | 39 | 1 |
| other | Supraventricular tachycardia | Cardiac disorders | Gemcitabine, 5-FU and Cisplatin | 1 | 39 | 2 |
| other | Ear and labyrinth disorders - Other | Ear and labyrinth disorders | Gemcitabine, 5-FU and Cisplatin | 1 | 39 | 1 |
| other | Hearing impaired | Ear and labyrinth disorders | Gemcitabine, 5-FU and Cisplatin | 1 | 39 | 1 |
| other | Blurred vision | Eye disorders | Gemcitabine, 5-FU and Cisplatin | 3 | 39 | 3 |
| other | Eye pain | Eye disorders | Gemcitabine, 5-FU and Cisplatin | 1 | 39 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Gemcitabine, 5-FU and Cisplatin | 1 | 39 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Gemcitabine, 5-FU and Cisplatin | 8 | 39 | 9 |
| other | Anal ulcer | Gastrointestinal disorders | Gemcitabine, 5-FU and Cisplatin | 1 | 39 | 1 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine, 5-FU and Cisplatin | ||
| Total, other adverse events | Gemcitabine, 5-FU and Cisplatin | 39 | 39 |
| Total, serious adverse events | Gemcitabine, 5-FU and Cisplatin | 10 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01661114
GET https://conductscience.org/api/trials/v1/NCT01661114/events?page=2