Trial · NCT00478361
Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
NCT00478361, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function. Trials, record NCT00478361. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00478361
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
- NCT number
- NCT00478361
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Distal Urethral Cancer, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Proximal Urethral Cancer, Recurrent Bladder Cancer, Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Regional Transitional Cell Cancer of the Renal Pelvis and Ureter, Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder, Urethral Cancer Associated With Invasive Bladder Cancer
- Interventions
- Gemcitabine hydrochloride, Paclitaxel, Doxorubicin hydrochloride, Pegfilgrastim
- First posted
- 2007-05-24
- Last updated
- 2020-10-09
- Results first posted
- 2020-10-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate. | The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR. |
| Secondary | Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease | Registration Date of each participant for up to three years or death whichever came first | The overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome. |
| Secondary | Safety and Efficacy of Same-day Pegfilgrastim | Up to 3 years | Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils. |
Source ClinicalTrials.gov
Outcomes3
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 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate. | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease | Registration Date of each participant for up to three years or death whichever came first | Hazard Ratio | NUMBER | |
| SECONDARY | Safety and Efficacy of Same-day Pegfilgrastim | Up to 3 years | Thirty-two patients (82%) received Pegfilgrastim immediately after chemotherapy on day 1 of the cycle. | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Objective Response Rate | Gemcitabine, Paclitaxel and Doxorubicin | 56.4 | 95% Confidence Interval 39.6 to 72.2 | percentage of participants | |
| Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease | Gemcitabine, Paclitaxel and Doxorubicin | Complete Response | 0.25 | 95% Confidence Interval 0.07 to 0.95 | Hazard Ratio |
| Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease | Gemcitabine, Paclitaxel and Doxorubicin | Partial Response | 1.09 | 95% Confidence Interval 0.44 to 2.70 | Hazard Ratio |
| Safety and Efficacy of Same-day Pegfilgrastim | Gemcitabine, Paclitaxel and Doxorubicin | Neutropenic Fever | 4 | participants | |
| Safety and Efficacy of Same-day Pegfilgrastim | Gemcitabine, Paclitaxel and Doxorubicin | Treatment Delay | 0 | participants |
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, Paclitaxel and Doxorubicin | 39 | |
| Overall Study | COMPLETED | Gemcitabine, Paclitaxel and Doxorubicin | 39 | |
| Overall Study | NOT COMPLETED | Gemcitabine, Paclitaxel and Doxorubicin | 0 |
Source ClinicalTrials.gov
Adverse events115
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 | Hypoalbuminemia | Metabolism and nutrition disorders | Gemcitabine, Paclitaxel and Doxorubicin | 6 | 39 | 7 |
| other | Hyperkalemia | Metabolism and nutrition disorders | Gemcitabine, Paclitaxel and Doxorubicin | 6 | 39 | 6 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Gemcitabine, Paclitaxel and Doxorubicin | 2 | 39 | 2 |
| other | Platelet Count Decreased | Investigations | Gemcitabine, Paclitaxel and Doxorubicin | 13 | 39 | 28 |
| other | Anemia | Blood and lymphatic system disorders | Gemcitabine, Paclitaxel and Doxorubicin | 32 | 39 | 73 |
| other | Fever | General disorders | Gemcitabine, Paclitaxel and Doxorubicin | 3 | 39 | 3 |
| other | Hyperuricemia | Metabolism and nutrition disorders | Gemcitabine, Paclitaxel and Doxorubicin | 10 | 39 | 10 |
| other | Skin and Subcutaneous Tissue Disorders - Nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Gemcitabine, Paclitaxel and Doxorubicin | 1 | 39 | 1 |
| other | Creatinine Increased | Investigations | Gemcitabine, Paclitaxel and Doxorubicin | 26 | 39 | 38 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Gemcitabine, Paclitaxel and Doxorubicin | 14 | 39 | 18 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gemcitabine, Paclitaxel and Doxorubicin | ||
| Total, other adverse events | Gemcitabine, Paclitaxel and Doxorubicin | 34 | 39 |
| Total, serious adverse events | Gemcitabine, Paclitaxel and Doxorubicin | 39 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| U10CA045809 | The UT MD Anderson Cancer Center Community Clinical Oncology Program Research Bas | WOLFF, ROBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1987 to 2013 |
Source NIH RePORTER
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/NCT00478361
GET https://conductscience.org/api/trials/v1/NCT00478361/events?page=2