Trial · NCT00361842
Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
NCT00361842, Phase 2, Completed, Jazz Pharmaceuticals; results first posted 2021-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer. Trials, record NCT00361842. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00361842
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
- NCT number
- NCT00361842
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Colorectal Neoplasms
- Interventions
- CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
- First posted
- 2006-08-09
- Last updated
- 2021-07-02
- Results first posted
- 2021-07-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months | Disease response was assessed using RECIST 1.0. Measurable disease and target lesions were determined prior to study entry. Changes in the largest diameter (unidimensional measurement) of the sum of the target tumor lesions were used in the RECIST criteria. Best response on study was classified as follows. Complete Response (CR), disappearance of all clinical and radiological evidence of tumor. Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of the longest diameters. Stable Disease (SD), steady state of disease. Neither sufficient shrinkage to qualify for PR or sufficient increase to qualify for PD. Progressive Disease (PD) at least a 20% increase in the sum of the longest diameters of measured lesions taking as references the smallest sum of longest diameters recorded since the treatment started. Appearance of new lesions also constituted progressive disease. |
| Primary | Progression-free Survival (PFS) Per RECIST Version 1.0 | Every 8 weeks | Progression-free survival (PFS) was defined as the time from the first dose to the documentation of progressive disease (PD), death, or lost to follow-up at last assessment visit. |
| Secondary | Duration of Response (DoR) Per RECIST Version 1.0 | Every 8 weeks | The duration of overall response was measured from the time that measurement criteria were met for CR or PR (whichever status was recorded first) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall complete response was measured from the time measurement criteria were first met for complete response until the first date that recurrent disease was objectively documented. |
Source ClinicalTrials.gov
Outcomes3
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) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months | The response rate efficacy evaluable (RECIST) analysis set (n=21 in group 1 and n= 24 in group 2) included all enrolled participants who received at least 1 cycle of CPX-1 therapy (2 doses, Days 1 and 15) and had at least 1 measurable lesion assessed for response (either after every second cycle of treatment or earlier to document disease progression) after beginning treatment. Tumor response, based on the RECIST criteria, was assessed at baseline and every 8 weeks. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (PFS) Per RECIST Version 1.0 | Every 8 weeks | The efficacy evaluable analysis set or Full Analysis Set (25 patients in Group 1 and 32 participants in Group 2) included all enrolled participants who received at least 1 dose of CPX-1 therapy, and had at least one post-baseline PFS assessment. | months | MEAN |
| SECONDARY | Duration of Response (DoR) Per RECIST Version 1.0 | Every 8 weeks | No participants had CR. Two participants in the naïve group had objective responses. One participant showed a PR on study day 57 that lasted for 5.8 months. One participant had a PR starting on study day 60 and persisting for 9.1 months at which time the data was censored. Due to the censored observation, the median DoR was not estimable (NE). | months | MEDIAN |
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) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Naïve | Complete Response (CR) | 0 | Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Exposed | Complete Response (CR) | 0 | Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Naïve | Partial Response (PR) | 2 | Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Exposed | Partial Response (PR) | 0 | Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Naïve | Stable Disease (SD) | 11 | Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Exposed | Stable Disease (SD) | 12 | Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Naïve | Progressive Disease (PD) | 8 | Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 | Irinotecan - Exposed | Progressive Disease (PD) | 11 | Participants | |
| Progression-free Survival (PFS) Per RECIST Version 1.0 | Irinotecan - Naïve | 4.69 | Standard Error 0.84 | months | |
| Progression-free Survival (PFS) Per RECIST Version 1.0 | Irinotecan - Exposed | 3.48 | Standard Error 0.44 | months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Irinotecan - Naïve | 28 | |
| Overall Study | STARTED | Irinotecan - Exposed | 35 | |
| Overall Study | COMPLETED | Irinotecan - Naïve | 1 | |
| Overall Study | COMPLETED | Irinotecan - Exposed | 1 | |
| Overall Study | NOT COMPLETED | Irinotecan - Naïve | 27 | |
| Overall Study | NOT COMPLETED | Irinotecan - Exposed | 34 |
Source ClinicalTrials.gov
Adverse events140
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 | Irinotecan - Naïve | 5 | 26 | |
| other | Anemia | Blood and lymphatic system disorders | Irinotecan - Exposed | 5 | 33 | |
| other | Neutropenia | Blood and lymphatic system disorders | Irinotecan - Naïve | 5 | 26 | |
| other | Neutropenia | Blood and lymphatic system disorders | Irinotecan - Exposed | 14 | 33 | |
| other | Abdominal Pain | Gastrointestinal disorders | Irinotecan - Naïve | 10 | 26 | |
| other | Abdominal Pain | Gastrointestinal disorders | Irinotecan - Exposed | 6 | 33 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Irinotecan - Naïve | 2 | 26 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Irinotecan - Exposed | 3 | 33 | |
| other | Constipation | Gastrointestinal disorders | Irinotecan - Naïve | 7 | 26 | |
| other | Constipation | Gastrointestinal disorders | Irinotecan - Exposed | 8 | 33 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Irinotecan - Naïve | 2 | 26 |
| Total, all-cause mortality | Irinotecan - Exposed | 4 | 33 |
| Total, other adverse events | Irinotecan - Naïve | 26 | 26 |
| Total, other adverse events | Irinotecan - Exposed | 33 | 33 |
| Total, serious adverse events | Irinotecan - Naïve | 13 | 26 |
| Total, serious adverse events | Irinotecan - Exposed | 11 | 33 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Irinotecan - Naïve vs Irinotecan - Exposed: deaths from any cause | Trial comparisons |
| Irinotecan - Naïve vs Irinotecan - Exposed: serious adverse events | Trial comparisons |
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/NCT00361842
GET https://conductscience.org/api/trials/v1/NCT00361842/events?page=2