Trial · NCT00942331
Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
NCT00942331, Phase 3, Completed, National Cancer Institute (NCI); results first posted 2020-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer. Trials, record NCT00942331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00942331
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
- NCT number
- NCT00942331
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 506 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Advanced Urothelial Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Prostate Carcinoma, Metastatic Renal Pelvis Urothelial Carcinoma, Metastatic Ureter Urothelial Carcinoma, Metastatic Urethral Urothelial Carcinoma, Metastatic Urothelial Carcinoma, Stage IV Bladder Urothelial Carcinoma AJCC v7, Stage IV Prostate Cancer AJCC v7, Stage IV Renal Pelvis Cancer AJCC v7, Stage IV Ureter Cancer AJCC v7, Stage IV Urethral Cancer AJCC v7, Unresectable Urothelial Carcinoma
- Interventions
- Bevacizumab, Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Placebo Administration
- First posted
- 2009-07-20
- Last updated
- 2026-06-24
- Results first posted
- 2020-02-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From date of randomization to date of death due to any cause, assessed up to 7 years | Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS. |
| Secondary | Progression-free Survival (PFS) | From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years | The primary analysis of PFS will be a two-sided stratified log-rank test comparing arm A and arm B. The stratification factors will consist of the two stratification factors used for patient randomization: prior nephrectomy (yes vs. no) and Motzer score (0 vs. 1-2 vs. 3+). Results from unstratified log-rank tests will also be provided. Kaplan-Meier methodology will be used to estimate median PFS for each treatment arm. |
| Secondary | Objective Response | Up to 7 years | Objective response is defined as confirmed complete and partial responses using Response Evaluation Criteria in Solid Tumors criteria. A complete response (CR) is defined as a disappearance of all target lesions. A partial response (PR) is defined as having at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum. In each arm, the number of patients reporting a CR or PR was divided by the number of patients evaluable in each arm to obtain the proportion. |
| Secondary | Number of Patients Experiencing Grade 3+ Toxicity | Up to 7 years | The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below. |
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 | Overall Survival (OS) | From date of randomization to date of death due to any cause, assessed up to 7 years | Intent to treat (ITT) analysis population | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years | months | MEDIAN | |
| SECONDARY | Objective Response | Up to 7 years | All patients registered, eligible and assessed for a response are included in this analysis. | proportion of participants | NUMBER |
| SECONDARY | Number of Patients Experiencing Grade 3+ Toxicity | Up to 7 years | Patients who started treatment are evaluable for adverse events. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm II (GCB) | 14.5 | 95% Confidence Interval 13.5 to 16.2 | months | |
| Overall Survival (OS) | Arm I (GCP) | 14.3 | 95% Confidence Interval 12.1 to 16.2 | months | |
| Progression-free Survival (PFS) | Arm II (GCB) | 8.0 | 95% Confidence Interval 7.1 to 8.5 | months | |
| Progression-free Survival (PFS) | Arm I (GCP) | 6.7 | 95% Confidence Interval 6.3 to 7.4 | months | |
| Objective Response | Arm II (GCB) | 0.4 | proportion of participants | ||
| Objective Response | Arm I (GCP) | 0.36 | proportion of participants | ||
| Number of Patients Experiencing Grade 3+ Toxicity | Arm II (GCB) | 183 | Participants | ||
| Number of Patients Experiencing Grade 3+ Toxicity | Arm I (GCP) | 163 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm II (GCB) | 252 | |
| Overall Study | STARTED | Arm I (GCP) | 254 | |
| Overall Study | COMPLETED | Arm II (GCB) | 237 | |
| Overall Study | COMPLETED | Arm I (GCP) | 232 | |
| Overall Study | NOT COMPLETED | Arm II (GCB) | 15 | |
| Overall Study | NOT COMPLETED | Arm I (GCP) | 22 |
Source ClinicalTrials.gov
Adverse events666
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 | Blood disorder | Blood and lymphatic system disorders | Arm II (GCB) | 0 | 237 | 0 |
| other | Blood disorder | Blood and lymphatic system disorders | Arm I (GCP) | 2 | 232 | 2 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II (GCB) | 4 | 237 | 9 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I (GCP) | 2 | 232 | 2 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm II (GCB) | 184 | 237 | 1,066 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Arm I (GCP) | 176 | 232 | 1,079 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm II (GCB) | 0 | 237 | 0 |
| other | Hemolysis | Blood and lymphatic system disorders | Arm I (GCP) | 1 | 232 | 1 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Arm II (GCB) | 0 | 237 | 0 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Arm I (GCP) | 1 | 232 | 1 |
1 to 10 of 666Source ClinicalTrials.gov
See all 666 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm II (GCB) | 207 | 252 |
| Total, all-cause mortality | Arm I (GCP) | 216 | 254 |
| Total, other adverse events | Arm II (GCB) | 215 | 237 |
| Total, other adverse events | Arm I (GCP) | 205 | 232 |
| Total, serious adverse events | Arm II (GCB) | 95 | 237 |
| Total, serious adverse events | Arm I (GCP) | 87 | 232 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm II (GCB) vs Arm I (GCP): Number of Patients Experiencing Grade 3+ Toxicity | Trial comparisons |
| Arm II (GCB) vs Arm I (GCP): deaths from any cause | Trial comparisons |
| Arm II (GCB) vs Arm I (GCP): serious adverse events | Trial comparisons |
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/NCT00942331
GET https://conductscience.org/api/trials/v1/NCT00942331/events?page=2