Trial · NCT01007552
A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts
NCT01007552, Phase 2, Completed, Roswell Park Cancer Institute; results first posted 2017-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts. Trials, record NCT01007552. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01007552
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts
- NCT number
- NCT01007552
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
- Cholangiocarcinoma
- Interventions
- Gemcitabine, Capecitabine and Bevacizumab
- First posted
- 2009-11-04
- Last updated
- 2017-03-29
- Results first posted
- 2017-03-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term "evaluable" in reference to measurability will not be used because it does not provide additional meaning or accuracy. |
| Secondary | Estimate the Proportion of Patients With Clinical Response | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Assess the Toxicity of the Regimen. | up to 5 years | Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail. |
| Secondary | Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers. | Baseline, Day 22 and Day 43 | We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life. For a Detailed description see: Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239. No subscales were analyzed. . |
| Secondary | Assess Overall Survival (OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | |
| Secondary | Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43 | baseline, day 22 and day 43 | Mean number of CTCs in 7.5 ml of whole blood |
| Secondary | Collect Samples at Baseline, Day 8 and Day 43 for Future Biomarker Studies and Development of Profiles of Responders to Anti-VEGF Therapy (Optional) | Baseline, day 8 and day 43 | This was a tissue banking end point of sample collection for future studies. No analysis was completed. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | All treated and eligible patients | months | MEDIAN |
| SECONDARY | Estimate the Proportion of Patients With Clinical Response | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | All treated and eligible patients | percentage of participants | NUMBER |
| SECONDARY | Assess the Toxicity of the Regimen. | up to 5 years | All treated and eligible patients | participants | NUMBER |
| SECONDARY | Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers. | Baseline, Day 22 and Day 43 | All treated and eligible patients. Some measures were not complete for leading to missing values. | units on a scale | MEAN |
| SECONDARY | Assess Overall Survival (OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years | All treated and eligible patients | months | MEAN |
| SECONDARY | Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43 | baseline, day 22 and day 43 | All treated and eligible patients | cells | MEAN |
| SECONDARY | Collect Samples at Baseline, Day 8 and Day 43 for Future Biomarker Studies and Development of Profiles of Responders to Anti-VEGF Therapy (Optional) | Baseline, day 8 and day 43 | No patients were analyzed and no data were collected for this Outcome Measure. This was an optional aim and the research team decided to opted out of analyzing. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers. | Gemcitabine, Capecitabine and Bevacizumab | 8.1 | 95% Confidence Interval 5.3 to 9.9 | months | |
| Estimate the Proportion of Patients With Clinical Response | Gemcitabine, Capecitabine and Bevacizumab | 24 | 95% Confidence Interval 13 to 38 | percentage of participants | |
| Assess the Toxicity of the Regimen. | Gemcitabine, Capecitabine and Bevacizumab | 30 | participants | ||
| Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers. | Gemcitabine, Capecitabine and Bevacizumab | Baseline | 136.7 | Standard Deviation 20.8 | units on a scale |
| Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers. | Gemcitabine, Capecitabine and Bevacizumab | Cycle 2 | 135.6 | Standard Deviation 22.1 | units on a scale |
| Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers. | Gemcitabine, Capecitabine and Bevacizumab | Cycle 3 | 139.9 | Standard Deviation 16.7 | units on a scale |
| Assess Overall Survival (OS) | Gemcitabine, Capecitabine and Bevacizumab | 10.2 | 95% Confidence Interval 7.5 to 13.7 | months | |
| Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43 | Gemcitabine, Capecitabine and Bevacizumab | Baseline | 2.3 | Standard Deviation 0.9 | cells |
| Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43 | Gemcitabine, Capecitabine and Bevacizumab | Day 22 | 1.0 | Standard Deviation 0.4 | cells |
| Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43 | Gemcitabine, Capecitabine and Bevacizumab | Day 43 | 0.8 | Standard Deviation 0.7 | cells |
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 | Gemcitabine, Capecitabine and Bevacizumab | 50 | |
| Overall Study | COMPLETED | Gemcitabine, Capecitabine and Bevacizumab | 49 | |
| Overall Study | NOT COMPLETED | Gemcitabine, Capecitabine and Bevacizumab | 1 |
Source ClinicalTrials.gov
Adverse events247
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 | Anaemia | Blood and lymphatic system disorders | Gemcitabine, Capecitabine and Bevacizumab | 34 | 50 | 399 |
| other | Leukopenia | Blood and lymphatic system disorders | Gemcitabine, Capecitabine and Bevacizumab | 38 | 50 | 837 |
| other | Lymphopenia | Blood and lymphatic system disorders | Gemcitabine, Capecitabine and Bevacizumab | 34 | 50 | 369 |
| other | Neutropenia | Blood and lymphatic system disorders | Gemcitabine, Capecitabine and Bevacizumab | 29 | 50 | 522 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Gemcitabine, Capecitabine and Bevacizumab | 31 | 50 | 435 |
| other | Pericardial effusion | Cardiac disorders | Gemcitabine, Capecitabine and Bevacizumab | 2 | 50 | 6 |
| other | Tachycardia | Cardiac disorders | Gemcitabine, Capecitabine and Bevacizumab | 1 | 50 | 3 |
| other | Ear pain | Ear and labyrinth disorders | Gemcitabine, Capecitabine and Bevacizumab | 1 | 50 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Gemcitabine, Capecitabine and Bevacizumab | 1 | 50 | 3 |
| other | Abnormal sensation in eye | Eye disorders | Gemcitabine, Capecitabine and Bevacizumab | 1 | 50 | 3 |
1 to 10 of 247Source ClinicalTrials.gov
See all 247 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine, Capecitabine and Bevacizumab | ||
| Total, other adverse events | Gemcitabine, Capecitabine and Bevacizumab | 50 | 50 |
| Total, serious adverse events | Gemcitabine, Capecitabine and Bevacizumab | 30 | 50 |
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/NCT01007552
GET https://conductscience.org/api/trials/v1/NCT01007552/events?page=2