Trial · NCT03736720
Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin
NCT03736720, Phase 2, Terminated, Roswell Park Cancer Institute; results first posted 2023-12-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin. Trials, record NCT03736720. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03736720
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Liposomal Irinotecan, Fluorouracil and Leucovorin in Treating Patients With Refractory Advanced High Grade Neuroendocrine Cancer of Gastrointestinal, Unknown, or Pancreatic Origin
- NCT number
- NCT03736720
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Locally Advanced Digestive System Neuroendocrine Carcinoma, Locally Advanced Pancreatic Neuroendocrine Carcinoma, Metastatic Digestive System Neuroendocrine Carcinoma, Metastatic Pancreatic Neuroendocrine Carcinoma, Refractory Digestive System Neuroendocrine Carcinoma, Refractory Pancreatic Neuroendocrine Carcinoma, Unresectable Digestive System Neuroendocrine Carcinoma, Unresectable Pancreatic Neuroendocrine Carcinoma
- Interventions
- Fluorouracil, Leucovorin, Liposomal Irinotecan, Quality-of-Life Assessment
- First posted
- 2018-11-09
- Last updated
- 2025-01-30
- Results first posted
- 2023-12-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Within 6 months of treatment initiation | Will be summarized using frequencies and relative frequencies; with the ORR (= CR+PR / N) estimated using an 80% confidence interval obtained using Jeffrey's prior method. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. |
| Secondary | Overall Survival | From first dosing of study treatment combination to time of death or imitation of a new therapy, assessed up to 3 years | Will be summarized using standard Kaplan-Meier methods; where estimates of the median time will be obtained with 95% confidence intervals. |
| Secondary | Progression-free Survival Assessed by RECIST 1.1 | From first dosing of study treatment combination to disease progression, assessed up to 3 years | Will be summarized using standard Kaplan-Meier methods; where estimates of the median time will be obtained with 95% confidence intervals. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Time-to Treatment Failure | From enrollment to discontinuation of treatment, assessed up to 3 years | Will be summarized using standard Kaplan-Meier methods; where estimates of the median time will be obtained with 90% confidence intervals. |
| Secondary | Proportion of Patients Achieving an Objective Response Based on Prior Response to Platinum Etoposide | Up to 3 years | The objective response rate (ORR) is as described in the primary analysis. Here it is reported in the subset of patients that received prior platinum etoposide therapy. |
| Secondary | Clinical Benefit Response | Up to 3 years | Defined as either achievement of pronounced and sustained (\>=4 weeks contiguous) improvement in pain intensity, analgesic consumption, or performance status, or a combination of these, without any worsening in any of the other factors, or stability in pain intensity, analgesic consumption, and performance status with pronounced and sustained (\>= 4 weeks contiguous) weight gain. Will be treated as binary data and summarized using frequencies and relative frequencies. The clinical benefit response rate will be estimated using a 90% confidence interval obtained by Jeffrey?s prior method. |
| Secondary | Quality of Life (QOL) as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) | From treatment initiation until treatment completion/progression (up to 3 years). | Will be treated as quantitative data and summarized by time-point using the mean and standard deviation. The QOL scores at each follow-up time may be compared with base-line levels using the paired t-test or sign test. The overall QoL rating ranges from 0 (poor) to 10 (good). |
| Secondary | Incidence of Grade 3+ Treatment Related Adverse Events (TRAE) | Up to 3 years | Toxicities and adverse events will be summarized by attribution and grade using frequencies and relative frequencies. High grade (3+) toxicity and adverse event rates may be estimated using 90% confidence intervals obtained by Jeffrey's prior method. Data Safety Monitoring Board (DSMB) monitoring will also occur periodically to ensure safety of study subjects. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Within 6 months of treatment initiation | 2 patients were not evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | From first dosing of study treatment combination to time of death or imitation of a new therapy, assessed up to 3 years | months | MEDIAN | |
| SECONDARY | Progression-free Survival Assessed by RECIST 1.1 | From first dosing of study treatment combination to disease progression, assessed up to 3 years | months | MEDIAN | |
| SECONDARY | Time-to Treatment Failure | From enrollment to discontinuation of treatment, assessed up to 3 years | months | MEDIAN | |
| SECONDARY | Proportion of Patients Achieving an Objective Response Based on Prior Response to Platinum Etoposide | Up to 3 years | Only 4 patients received prior platinum etoposide. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit Response | Up to 3 years | The appropriate data to identify patient clinical benefit status (as defined above) was not adequately obtained (no available data) and analysis can not be conducted for this outcome measure. | ||
| SECONDARY | Quality of Life (QOL) as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) | From treatment initiation until treatment completion/progression (up to 3 years). | There are 11 patients that have QoL data at baseline (pre-treatment). There are only 8 patients with end of treatment QoL assessment. | units on a scale | MEAN |
| SECONDARY | Incidence of Grade 3+ Treatment Related Adverse Events (TRAE) | Up to 3 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | Objective Response (CR+PR) | 1 | Participants | |
| Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | No Objective Response (SD+PD) | 8 | Participants | |
| Overall Survival | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 8.3 | 95% Confidence Interval 2.3 to 18.2 | months | |
| Progression-free Survival Assessed by RECIST 1.1 | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 3.9 | 95% Confidence Interval 0.5 to 5.1 | months | |
| Time-to Treatment Failure | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 3.9 | 90% Confidence Interval 1.7 to 4.4 | months | |
| Proportion of Patients Achieving an Objective Response Based on Prior Response to Platinum Etoposide | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | No Objective Response | 3 | Participants | |
| Proportion of Patients Achieving an Objective Response Based on Prior Response to Platinum Etoposide | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | Objective Response | 1 | Participants | |
| Quality of Life (QOL) as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | Pre Treatment QoL | 5.9 | Standard Deviation 1.4 | units on a scale |
| Quality of Life (QOL) as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | End of Treatment QoL | 5.5 | Standard Deviation 1.7 | units on a scale |
| Incidence of Grade 3+ Treatment Related Adverse Events (TRAE) | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | No Grade 3+ TRAE | 4 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 11 | |
| Overall Study | COMPLETED | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 11 | |
| Overall Study | NOT COMPLETED | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 0 |
Source ClinicalTrials.gov
Adverse events26
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 | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 1 | 11 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 1 | 11 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 2 | 11 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 5 | 11 | 5 |
| other | Gastrointestinal pain | Gastrointestinal disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 1 | 11 | 1 |
| other | Nausea | Gastrointestinal disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 5 | 11 | 5 |
| other | Small intestinal obstruction | Gastrointestinal disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 1 | 11 | 1 |
| other | Vomiting | Gastrointestinal disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 5 | 11 | 5 |
| other | Fatigue | General disorders | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 5 | 11 | 5 |
| other | Sepsis | Infections and infestations | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 2 | 11 | 2 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 1 | 11 |
| Total, other adverse events | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 11 | 11 |
| Total, serious adverse events | Treatment (Liposomal Irinotecan, Leucovorin, Fluorouracil) | 6 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33835977 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT03736720
GET https://conductscience.org/api/trials/v1/NCT03736720/events?page=2