Trial · NCT00356889
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
NCT00356889, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-05-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors. Trials, record NCT00356889. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00356889
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
- NCT number
- NCT00356889
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 56 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Gastrointestinal Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
- Interventions
- erlotinib hydrochloride, bevacizumab
- First posted
- 2006-07-27
- Last updated
- 2014-05-28
- Results first posted
- 2013-05-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Confirmed Tumor Responses. | After 6 courses of treatment. Each course lasts 28 days. | Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the target lesions. A confirmed tumor response is defined to be either a Complete Response or a Partial Response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Confirmed tumor responses will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment and had one post-baseline disease assessment will be evaluable for response. Forty-nine of the 53 eligible patients had at least one post-baseline disease assessment and were evaluable for this endpoint. |
| Secondary | Survival Time | From registration to death due to any cause, assessed up to 3 years | Estimated using the method of Kaplan-Meier (1958). |
| Secondary | Time to Disease Progression | From registration to documentation of disease progression, assessed up to 3 years | Estimated using the method of Kaplan-Meier (1958). |
| Secondary | Duration of Response | From 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, assessed up to 3 years | Point estimates and 95% confidence intervals were calculated using the method of Duffy and Santner (1987). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Confirmed Tumor Responses. | After 6 courses of treatment. Each course lasts 28 days. | participants | NUMBER | |
| SECONDARY | Survival Time | From registration to death due to any cause, assessed up to 3 years | months | MEDIAN | |
| SECONDARY | Time to Disease Progression | From registration to documentation of disease progression, assessed up to 3 years | months | MEDIAN | |
| SECONDARY | Duration of Response | From 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, assessed up to 3 years | There were 6 patients with a confirmed Partial Response. | 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 |
|---|---|---|---|---|---|
| Number of Confirmed Tumor Responses. | Bevacizumab and Erlotinib Hydrochloride | Partial Response (PR) | 6 | participants | |
| Number of Confirmed Tumor Responses. | Bevacizumab and Erlotinib Hydrochloride | Complete Response (CR) | 0 | participants | |
| Survival Time | Bevacizumab and Erlotinib Hydrochloride | 9.9 | 95% Confidence Interval 7.2 to 13.6 | months | |
| Time to Disease Progression | Bevacizumab and Erlotinib Hydrochloride | 4.4 | 95% Confidence Interval 3.0 to 7.8 | months | |
| Duration of Response | Bevacizumab and Erlotinib Hydrochloride | 8.4 | 95% Confidence Interval 6.0 to 11.7 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab and Erlotinib Hydrochloride | 56 | |
| Overall Study | COMPLETED | Bevacizumab and Erlotinib Hydrochloride | 53 | |
| Overall Study | NOT COMPLETED | Bevacizumab and Erlotinib Hydrochloride | 3 |
Source ClinicalTrials.gov
Adverse events137
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 | Bevacizumab and Erlotinib Hydrochloride | 10 | 55 | 28 |
| other | Hemolysis | Blood and lymphatic system disorders | Bevacizumab and Erlotinib Hydrochloride | 1 | 55 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Bevacizumab and Erlotinib Hydrochloride | 1 | 55 | 1 |
| other | Cataract | Eye disorders | Bevacizumab and Erlotinib Hydrochloride | 1 | 55 | 1 |
| other | Conjunctivitis | Eye disorders | Bevacizumab and Erlotinib Hydrochloride | 1 | 55 | 2 |
| other | Dry eye syndrome | Eye disorders | Bevacizumab and Erlotinib Hydrochloride | 2 | 55 | 3 |
| other | Eye disorder | Eye disorders | Bevacizumab and Erlotinib Hydrochloride | 3 | 55 | 7 |
| other | Keratitis | Eye disorders | Bevacizumab and Erlotinib Hydrochloride | 1 | 55 | 1 |
| other | Vision blurred | Eye disorders | Bevacizumab and Erlotinib Hydrochloride | 1 | 55 | 2 |
| other | Watering eyes | Eye disorders | Bevacizumab and Erlotinib Hydrochloride | 1 | 55 | 1 |
1 to 10 of 137Source ClinicalTrials.gov
See all 137 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab and Erlotinib Hydrochloride | ||
| Total, other adverse events | Bevacizumab and Erlotinib Hydrochloride | 54 | 55 |
| Total, serious adverse events | Bevacizumab and Erlotinib Hydrochloride | 22 | 55 |
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/NCT00356889
GET https://conductscience.org/api/trials/v1/NCT00356889/events?page=2