Trial · NCT00433550
Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
NCT00433550, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2017-08-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer. Trials, record NCT00433550. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00433550
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
- NCT number
- NCT00433550
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Small Intestine Adenocarcinoma, Recurrent Small Intestine Cancer
- Interventions
- capecitabine, irinotecan hydrochloride, oxaliplatin
- First posted
- 2007-02-12
- Last updated
- 2017-08-24
- Results first posted
- 2017-08-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Tumor Response Rate (Proportion of Participants With Complete Response) | 36 weeks | Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants. |
| Secondary | Overall Survival | Up to 2 years | Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology. |
| Secondary | Progression Free Survival | Up to 2 years | Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. 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. The distribution of time to progression will be estimated using Kaplan-Meier methodology. |
| Secondary | Duration of Response | Up to 2 years | Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods. |
| Secondary | Time to Treatment Failure | Up to 2 years | Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Tumor Response Rate (Proportion of Participants With Complete Response) | 36 weeks | One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint. | proportion of patients | NUMBER |
| SECONDARY | Overall Survival | Up to 2 years | One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint. | months | MEDIAN |
| SECONDARY | Progression Free Survival | Up to 2 years | One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint. | months | MEDIAN |
| SECONDARY | Duration of Response | Up to 2 years | All patients who achieved a CR or PR are included in this analysis. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | Up to 2 years | One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Tumor Response Rate (Proportion of Participants With Complete Response) | All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | .38 | 95% Confidence Interval .21 to .56 | proportion of patients | |
| Overall Survival | All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 13.4 | 95% Confidence Interval 10.5 to 18.1 | months | |
| Progression Free Survival | All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 8.9 | 95% Confidence Interval 4.7 to 10.8 | months | |
| Duration of Response | All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 9.0 | 95% Confidence Interval 7.8 to NA | months | |
| Time to Treatment Failure | All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype) | 6.7 | 95% Confidence Interval 4.3 to 10.6 | months |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 (6/6 UGT1A1 Genotype) | 17 | |
| Overall Study | STARTED | Group 2 (6/7 UGT1A1 Genotype) | 10 | |
| Overall Study | STARTED | Group 3 (7/7 UGT1A1 Genotype) | 6 | |
| Overall Study | COMPLETED | Group 1 (6/6 UGT1A1 Genotype) | 17 | |
| Overall Study | COMPLETED | Group 2 (6/7 UGT1A1 Genotype) | 10 | |
| Overall Study | COMPLETED | Group 3 (7/7 UGT1A1 Genotype) | 6 | |
| Overall Study | NOT COMPLETED | Group 1 (6/6 UGT1A1 Genotype) | 0 | |
| Overall Study | NOT COMPLETED | Group 2 (6/7 UGT1A1 Genotype) | 0 | |
| Overall Study | NOT COMPLETED | Group 3 (7/7 UGT1A1 Genotype) | 0 |
Source ClinicalTrials.gov
Adverse events261
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 | Hemoglobin decreased | Blood and lymphatic system disorders | Group 1 (6/6 UGT1A1 Genotype) | 13 | 17 | 120 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Group 2 (6/7 UGT1A1 Genotype) | 10 | 10 | 58 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Group 3 (7/7 UGT1A1 Genotype) | 6 | 6 | 57 |
| other | Cardiac disorder | Cardiac disorders | Group 1 (6/6 UGT1A1 Genotype) | 0 | 17 | 0 |
| other | Cardiac disorder | Cardiac disorders | Group 2 (6/7 UGT1A1 Genotype) | 0 | 10 | 0 |
| other | Cardiac disorder | Cardiac disorders | Group 3 (7/7 UGT1A1 Genotype) | 1 | 6 | 1 |
| other | Hearing loss | Ear and labyrinth disorders | Group 1 (6/6 UGT1A1 Genotype) | 0 | 17 | 0 |
| other | Hearing loss | Ear and labyrinth disorders | Group 2 (6/7 UGT1A1 Genotype) | 0 | 10 | 0 |
| other | Hearing loss | Ear and labyrinth disorders | Group 3 (7/7 UGT1A1 Genotype) | 1 | 6 | 2 |
| other | Eye disorder | Eye disorders | Group 1 (6/6 UGT1A1 Genotype) | 1 | 17 | 1 |
1 to 10 of 261Source ClinicalTrials.gov
See all 261 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 (6/6 UGT1A1 Genotype) | ||
| Total, all-cause mortality | Group 2 (6/7 UGT1A1 Genotype) | ||
| Total, all-cause mortality | Group 3 (7/7 UGT1A1 Genotype) | ||
| Total, other adverse events | Group 1 (6/6 UGT1A1 Genotype) | 16 | 17 |
| Total, other adverse events | Group 2 (6/7 UGT1A1 Genotype) | 10 | 10 |
| Total, other adverse events | Group 3 (7/7 UGT1A1 Genotype) | 6 | 6 |
| Total, serious adverse events | Group 1 (6/6 UGT1A1 Genotype) | 7 | 17 |
| Total, serious adverse events | Group 2 (6/7 UGT1A1 Genotype) | 6 | 10 |
| Total, serious adverse events | Group 3 (7/7 UGT1A1 Genotype) | 1 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24114122 | DERIVED |
Source PubMed
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/NCT00433550
GET https://conductscience.org/api/trials/v1/NCT00433550/events?page=2