Trial · NCT00085410
Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
NCT00085410, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder. Trials, record NCT00085410. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00085410
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
- NCT number
- NCT00085410
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Advanced Adult Primary Liver Cancer, Gastrointestinal Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
- Interventions
- bortezomib
- First posted
- 2004-06-11
- Last updated
- 2017-07-02
- Results first posted
- 2017-06-14
- Limitations and caveats
- The trial was discontinued early due to no confirmed partial responses.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Up to 1 year | Objective Response Rate (ORR) was determined by best response on radiologic assessment (computed tomography or magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. |
| Secondary | Time to Disease Progression | Up to 1 year | Time from initiation of therapy to first progressive disease. |
| Secondary | Overall Survival | Up to 1 year | The time from initiation of therapy to death or last follow-up. |
| Secondary | Correlation of the Degree of Proteasome Inhibition in Peripheral Blood With the Degree of Proteasome Inhibition in Tumor Specimens | Once in the screening period (within 14 days of starting treatment) | Proteasome inhibition compared between tumor specimens and peripheral blood. Sufficient tissue samples are required for this analysis. |
| Secondary | Correlation of Phenotypic Expression of NF-kB, p53, and Other Molecular Markers in Biliary Washings and Tumor Biopsies With Clinical Outcomes | Once in the screening period (within 14 days of starting treatment) | Evaluation of clinical outcomes with expression of molecular markers specified and others. Sufficient amount of biliary washings and tumor biopsies needed for analysis. |
| Secondary | Correlation of Treatment With Changes in Phenotypic Expression of Molecular Markers | Duration of study treatment | Phenotypic expression of molecular markers before and after study treatment |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | Up to 1 year | Per protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Disease Progression | Up to 1 year | 1 patient who withdrew consent prior to the first disease evaluation was excluded. | months | MEDIAN |
| SECONDARY | Overall Survival | Up to 1 year | 1 patient who withdrew consent prior to the first disease evaluation was excluded. | months | MEDIAN |
| SECONDARY | Correlation of the Degree of Proteasome Inhibition in Peripheral Blood With the Degree of Proteasome Inhibition in Tumor Specimens | Once in the screening period (within 14 days of starting treatment) | Insufficient amount of patient samples collected for analysis | ||
| SECONDARY | Correlation of Phenotypic Expression of NF-kB, p53, and Other Molecular Markers in Biliary Washings and Tumor Biopsies With Clinical Outcomes | Once in the screening period (within 14 days of starting treatment) | Insufficient amount of patient samples collected for analysis | ||
| SECONDARY | Correlation of Treatment With Changes in Phenotypic Expression of Molecular Markers | Duration of study treatment | Insufficient amount of patient samples collected for analysis | ||
| POST_HOC | Clinical Benefit Rate | Up to 1 year | 1 patient who withdrew consent prior to the first disease evaluation was excluded. | percentage of patients | NUMBER |
| POST_HOC | 6-Month Survival | 6 months | 1 patient who withdrew consent prior to the first disease evaluation was excluded. | percentage of patients | NUMBER |
| POST_HOC | 1-year Survival | 1 year | 1 patient who withdrew consent prior to the first disease evaluation was excluded. | percentage of patients | NUMBER |
| POST_HOC | 6-Month and 1-Year Survival for Patients Who Derived Clinical Benefit From Study Treatment | Up to 1 year | Patients who derived benefit from study treatment (stable disease, partial response, or complete response was best response) | percentage of patients | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | Arm I | Stable Disease | 10 | Participants | |
| Objective Response Rate | Arm I | Partial Response (Unconfirmed) | 1 | Participants | |
| Objective Response Rate | Arm I | Progressive Disease | 8 | Participants | |
| Objective Response Rate | Arm I | Withdrew Consent Before Evaluation | 1 | Participants | |
| Time to Disease Progression | Arm I | 5.8 | 95% Confidence Interval 0.7 to 77.6 | months | |
| Overall Survival | Arm I | 9 | 95% Confidence Interval 4.6 to 18.5 | months | |
| Clinical Benefit Rate | Arm I | Patients who received prior therapy | 21 | percentage of patients | |
| Clinical Benefit Rate | Arm I | Patients who did not receive prior therapy | 32 | percentage of patients | |
| 6-Month Survival | Arm I | 70 | percentage of patients | ||
| 1-year Survival | Arm I | 38 | percentage of patients |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I | 20 | |
| Overall Study | COMPLETED | Arm I | 20 | |
| Overall Study | NOT COMPLETED | Arm I | 0 |
Source ClinicalTrials.gov
Adverse events23
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 I | 15 | 20 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm I | 5 | 20 | |
| other | Neutropenia | Infections and infestations | Arm I | 5 | 20 | |
| other | thrombocytopenia | Skin and subcutaneous tissue disorders | Arm I | 14 | 20 | |
| other | Dehydration | Gastrointestinal disorders | Arm I | 3 | 20 | |
| other | dizziness | Nervous system disorders | Arm I | 4 | 20 | |
| other | Edema | General disorders | Arm I | 5 | 20 | |
| other | Elevated alkaline phosphatase | Metabolism and nutrition disorders | Arm I | 3 | 20 | |
| other | Elevated AST/ALT | Metabolism and nutrition disorders | Arm I | 7 | 20 | |
| other | Elevated creatinine | Metabolism and nutrition disorders | Arm I | 3 | 20 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, other adverse events | Arm I | 20 | 20 |
| Total, serious adverse events | Arm I | 4 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24512954 | RESULT |
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/NCT00085410
GET https://conductscience.org/api/trials/v1/NCT00085410/events?page=2