Trial · NCT00478140
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
NCT00478140, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2013-11-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery. Trials, record NCT00478140. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00478140
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
- NCT number
- NCT00478140
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adenocarcinoma of the Extrahepatic Bile Duct, Adenocarcinoma of the Gallbladder, Malignant Neoplasm, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
- Interventions
- trastuzumab, laboratory biomarker analysis
- First posted
- 2007-05-24
- Last updated
- 2019-08-20
- Results first posted
- 2013-11-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (Complete and Partial Response) | Baseline to 63 days or until disease progression | Response assessed using imaging-based evaluation at baseline then following single agent trastuzumab administered over 21 day cycle, re-staging done following 2 cycles. Response Evaluation Criteria in Solid Tumors defined as Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; 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; 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. |
| Secondary | Disease Control Rate | Up to 3.5 years | Percentage of participants who have achieved complete response, partial response and stable disease |
| Secondary | Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 3 years | Participant toxicity for study as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 reported in Results Adverse Event Reporting of record. |
| Secondary | Overall Survival | Up to 3.5 years | Length of time from date of starting treatment that participants are still alive |
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 | Objective Response (Complete and Partial Response) | Baseline to 63 days or until disease progression | Only those participants who had measurable disease present at baseline, received at least one cycle of therapy, and had disease re-evaluated considered evaluable for response; therefore one participant was inevaluable. | participants | NUMBER |
| SECONDARY | Disease Control Rate | Up to 3.5 years | percentage of participants | NUMBER | |
| SECONDARY | Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Up to 3 years | participants | NUMBER | |
| SECONDARY | Overall Survival | Up to 3.5 years | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (Complete and Partial Response) | Trastuzumab | Complete Response | 1 | participants | |
| Objective Response (Complete and Partial Response) | Trastuzumab | Partial Response | 0 | participants | |
| Objective Response (Complete and Partial Response) | Trastuzumab | Progressive Disease | 1 | participants | |
| Objective Response (Complete and Partial Response) | Trastuzumab | Stable Disease | 1 | participants | |
| Disease Control Rate | Trastuzumab | 67 | percentage of participants | ||
| Number of Participant With Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Trastuzumab | 3 | participants | ||
| Overall Survival | Trastuzumab | 65 | Full Range 9.4 to 127 | weeks |
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 | Trastuzumab | 4 | |
| Overall Study | COMPLETED | Trastuzumab | 3 | |
| Overall Study | NOT COMPLETED | Trastuzumab | 1 |
Source ClinicalTrials.gov
Adverse events43
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 distension | Gastrointestinal disorders | Trastuzumab | 2 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Trastuzumab | 3 | 4 | |
| other | Allergic reaction | Immune system disorders | Trastuzumab | 2 | 4 | |
| other | Allergic rhinitis | Immune system disorders | Trastuzumab | 2 | 4 | |
| other | Anorexia | Gastrointestinal disorders | Trastuzumab | 3 | 4 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Trastuzumab | 2 | 4 | |
| other | Ascites | Gastrointestinal disorders | Trastuzumab | 3 | 4 | |
| other | Diarrhea | Gastrointestinal disorders | Trastuzumab | 2 | 4 | |
| other | Fatigue | General disorders | Trastuzumab | 4 | 4 | |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Trastuzumab | 2 | 4 |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trastuzumab | ||
| Total, other adverse events | Trastuzumab | 4 | 4 |
| Total, serious adverse events | Trastuzumab | 0 | 4 |
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/NCT00478140
GET https://conductscience.org/api/trials/v1/NCT00478140/events?page=2