Trial · NCT00591123
Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
NCT00591123, Phase 2, Completed, Translational Oncology Research International; results first posted 2021-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia. Trials, record NCT00591123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00591123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
- NCT number
- NCT00591123
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Translational Oncology Research International
- Conditions
- Unresectable Adenocarcinoma of the Esophagus, Metastatic Adenocarcinoma of the Esophagus, Unresectable Adenocarcinoma of Gastric Cardia, Metastatic Adenocarcinoma of Gastric Cardia
- Interventions
- FOLFOX, 5-FU, Erlotinib
- First posted
- 2008-01-11
- Last updated
- 2021-10-01
- Results first posted
- 2021-10-01
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib. | 3.5 years | Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
| Secondary | Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | 3.5 years | Adverse event assessment by investigators and as reported by subjects from time of consent to 30 days after last dose. Up to 3.5 years. |
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 | Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib. | 3.5 years | 33 patients who were evaluable for response per protocol | percent of subjects that had response | NUMBER |
| SECONDARY | Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | 3.5 years | Number of subjects that experienced Grade 3 and 4 Adverse events associated with FOLFOX/5-FU/Erlotinib therapy | participants | NUMBER |
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 |
|---|---|---|---|---|---|
Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib. | FOLFOX Plus 5-FU and Erlotinib | 51.5 | percent of subjects that had response | ||
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Diarrhea / dehydration | 9 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Anorexia | 5 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Nausea/Vomiting | 4 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Rash | 3 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Fatigue | 4 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Peripheral neuropathy | 3 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Neutropenia | 5 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Neutropenic Fever | 1 | participants | |
| Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib | FOLFOX Plus 5-FU and Erlotinib | Hypokalemia | 2 | 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 | FOLFOX Plus 5-FU and Erlotinib | 38 | |
| Overall Study | COMPLETED | FOLFOX Plus 5-FU and Erlotinib | 38 | |
| Overall Study | NOT COMPLETED | FOLFOX Plus 5-FU and Erlotinib | 0 |
Source ClinicalTrials.gov
Adverse events153
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 | Abdominal distention | Gastrointestinal disorders | Single Arm | 1 | 38 | 1 |
| other | Alkaline Phosphatase - elevated | Blood and lymphatic system disorders | Single Arm | 11 | 38 | 13 |
| other | Alopecia | General disorders | Single Arm | 6 | 38 | 7 |
| other | Alanine Aminotransferase - elevated | Blood and lymphatic system disorders | Single Arm | 6 | 38 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Single Arm | 16 | 38 | 19 |
| other | Anorexia | Metabolism and nutrition disorders | Single Arm | 21 | 38 | 24 |
| other | Aspartate Aminotransferase - elevated | Blood and lymphatic system disorders | Single Arm | 9 | 38 | 12 |
| other | Blepharitis | Eye disorders | Single Arm | 1 | 38 | 1 |
| other | Bloating | General disorders | Single Arm | 5 | 38 | 6 |
| other | Blood in stool | Gastrointestinal disorders | Single Arm | 2 | 38 | 2 |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm | 1 | 38 |
| Total, other adverse events | Single Arm | 38 | 38 |
| Total, serious adverse events | Single Arm | 7 | 38 |
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/NCT00591123
GET https://conductscience.org/api/trials/v1/NCT00591123/events?page=2