Trial · NCT00042939
Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
NCT00042939, Phase 2, Completed, Eastern Cooperative Oncology Group; results first posted 2011-07-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer. Trials, record NCT00042939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00042939
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
- NCT number
- NCT00042939
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 94 participants, actual
- Lead sponsor
- Eastern Cooperative Oncology Group
- Conditions
- Pancreatic Cancer
- Interventions
- cetuximab, docetaxel, irinotecan hydrochloride
- First posted
- 2003-01-27
- Last updated
- 2023-07-06
- Results first posted
- 2011-07-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) | Assessed every 12 weeks until progression | Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= \>=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR |
| Secondary | Progression-free Survival | Assessed every 3 months for 2 years and then every 6 months for 1 year | Progression-free survival was defined as the shorter of: 1. The time from registration to progression. or 2. The time from registration to death without documentation of progression given that the death occured within 4 months of the last disease assessment without progression (or registration, whichever is more recent). Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions. |
| Secondary | Overall Survival | Assessed every 3 months for 2 years and then every 6 months for 1 year | Overall survival was defined as time from registration to death from any cause. |
| Secondary | Epidermal Growth Factor Receptor (EGFR) Status | Original tumor tissue samples submitted within one month of patient randomization | EGFR expression was be evaluated by staining 5-micron paraffin sections of tumor biopsies with anti-EGFR clone 2-18C9 (DAKO Corporation, Carpinteria, CA) using an indirect immunoperoxidase technique according to the instructions provided by DAKO. In brief, this includes an antigen retrieval pretreatment, the blocking of endogenous peroxidase activity, incubation with anti-EGFR antibody or a negative reagent control, staining with a detection system, visualization, and coverslipping. |
| Secondary | Proportion of Patients With Thromboembolic Events | Assessed every 6 weeks while on treatment and for 30 days after the end of treatment | To determine the rate of thromboembolic events in this population when prophylactic enoxaparin sodium is administered. |
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 | Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) | Assessed every 12 weeks until progression | Eligible patients who began treatment were included in the analysis. | Proportion of participants | NUMBER |
| SECONDARY | Progression-free Survival | Assessed every 3 months for 2 years and then every 6 months for 1 year | Eligible patients who began treatment. | months | MEDIAN |
| SECONDARY | Overall Survival | Assessed every 3 months for 2 years and then every 6 months for 1 year | Eligible patients who began treatment. | months | MEDIAN |
| SECONDARY | Epidermal Growth Factor Receptor (EGFR) Status | Original tumor tissue samples submitted within one month of patient randomization | Eligible and treated patients with EGFR stain results available. | participants | NUMBER |
| SECONDARY | Proportion of Patients With Thromboembolic Events | Assessed every 6 weeks while on treatment and for 30 days after the end of treatment | Eligible and treated patients | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) | Arm A: Irinotecan/Docetaxel | 0.045 | 90% Confidence Interval 0.015 to 0.184 | Proportion of participants | |
| Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria) | Arm B: Irinotecan/Docetaxel/Cetuximab | 0.07 | 90% Confidence Interval 0.024 to 0.198 | Proportion of participants | |
| Progression-free Survival | Arm A: Irinotecan/Docetaxel | 3.9 | 90% Confidence Interval 2.4 to 5.0 | months | |
| Progression-free Survival | Arm B: Irinotecan/Docetaxel/Cetuximab | 4.5 | 90% Confidence Interval 2.7 to 5.6 | months | |
| Overall Survival | Arm A: Irinotecan/Docetaxel | 6.5 | 90% Confidence Interval 5.6 to 9.9 | months | |
| Overall Survival | Arm B: Irinotecan/Docetaxel/Cetuximab | 5.3 | 90% Confidence Interval 4.5 to 9.4 | months | |
| Epidermal Growth Factor Receptor (EGFR) Status | Arm A: Irinotecan/Docetaxel | Positive | 29 | participants | |
| Epidermal Growth Factor Receptor (EGFR) Status | Arm B: Irinotecan/Docetaxel/Cetuximab | Positive | 30 | participants | |
| Epidermal Growth Factor Receptor (EGFR) Status | Arm A: Irinotecan/Docetaxel | Negative | 1 | participants | |
| Epidermal Growth Factor Receptor (EGFR) Status | Arm B: Irinotecan/Docetaxel/Cetuximab | Negative | 1 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Irinotecan/Docetaxel | 48 | |
| Overall Study | STARTED | Arm B: Irinotecan/Docetaxel/Cetuximab | 46 | |
| Overall Study | Treated | Arm A: Irinotecan/Docetaxel | 46 | |
| Overall Study | Treated | Arm B: Irinotecan/Docetaxel/Cetuximab | 45 | |
| Overall Study | Eligible and Began Protocol Therapy | Arm A: Irinotecan/Docetaxel | 44 | |
| Overall Study | Eligible and Began Protocol Therapy | Arm B: Irinotecan/Docetaxel/Cetuximab | 43 | |
| Overall Study | Patients With EGFR Results Available | Arm A: Irinotecan/Docetaxel | 30 | |
| Overall Study | Patients With EGFR Results Available | Arm B: Irinotecan/Docetaxel/Cetuximab | 31 | |
| Overall Study | COMPLETED | Arm A: Irinotecan/Docetaxel | 24 | |
| Overall Study | COMPLETED | Arm B: Irinotecan/Docetaxel/Cetuximab | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events222
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 | Arm A: Irinotecan/Docetaxel | 40 | 46 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B: Irinotecan/Docetaxel/Cetuximab | 41 | 45 | |
| other | Leukopenia | Investigations | Arm A: Irinotecan/Docetaxel | 33 | 46 | |
| other | Leukopenia | Investigations | Arm B: Irinotecan/Docetaxel/Cetuximab | 31 | 45 | |
| other | Neutropenia | Investigations | Arm A: Irinotecan/Docetaxel | 24 | 46 | |
| other | Neutropenia | Investigations | Arm B: Irinotecan/Docetaxel/Cetuximab | 24 | 45 | |
| other | Thrombocytopenia | Investigations | Arm A: Irinotecan/Docetaxel | 11 | 46 | |
| other | Thrombocytopenia | Investigations | Arm B: Irinotecan/Docetaxel/Cetuximab | 6 | 45 | |
| other | Edema | General disorders | Arm A: Irinotecan/Docetaxel | 5 | 46 | |
| other | Edema | General disorders | Arm B: Irinotecan/Docetaxel/Cetuximab | 5 | 45 |
1 to 10 of 222Source ClinicalTrials.gov
See all 222 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Irinotecan/Docetaxel | ||
| Total, all-cause mortality | Arm B: Irinotecan/Docetaxel/Cetuximab | ||
| Total, other adverse events | Arm A: Irinotecan/Docetaxel | 46 | 46 |
| Total, other adverse events | Arm B: Irinotecan/Docetaxel/Cetuximab | 45 | 45 |
| Total, serious adverse events | Arm A: Irinotecan/Docetaxel | 35 | 46 |
| Total, serious adverse events | Arm B: Irinotecan/Docetaxel/Cetuximab | 36 | 45 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm A: Irinotecan/Docetaxel vs Arm B: Irinotecan/Docetaxel/Cetuximab: serious adverse events |
Source 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/NCT00042939
GET https://conductscience.org/api/trials/v1/NCT00042939/events?page=2