Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

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secondary · POSTED

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.

Source null

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secondary · POSTED

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.

Thirty-two patients (82%) received Pegfilgrastim immediately after chemotherapy on day 1 of the cycle.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-urothelial-carcinoma-bavencio-ad600f37
nct id: NCT00478361
trial label: Gemcitabine, Paclitaxel, Doxorubicin in Metastatic or Unresectable Bladder Cancer With Decreased Kidney Function
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-ad600f37
nct id
NCT00478361
outcome key
om-0000
source section id
NCT00478361-om-0000
source outcome index
0
endpoint
Objective Response Rate
endpoint definition
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.
time origin
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.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-ad600f37
nct id
NCT00478361
outcome key
om-0001
source section id
NCT00478361-om-0001
source outcome index
1
endpoint
Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
endpoint definition
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.
time origin
Registration Date of each participant for up to three years or death whichever came first
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-ad600f37
nct id
NCT00478361
outcome key
om-0002
source section id
NCT00478361-om-0002
source outcome index
2
endpoint
Safety and Efficacy of Same-day Pegfilgrastim
endpoint definition
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.
time origin
Up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Thirty-two patients (82%) received Pegfilgrastim immediately after chemotherapy on day 1 of the cycle.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-ad600f37
nct id
NCT00478361
outcome key
om-0000
arm key
OG000
arm label
Gemcitabine, Paclitaxel and Doxorubicin
regimen
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00478361-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-ad600f37
nct id
NCT00478361
outcome key
om-0001
arm key
OG000
arm label
Gemcitabine, Paclitaxel and Doxorubicin
regimen
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00478361-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-ad600f37
nct id
NCT00478361
outcome key
om-0002
arm key
OG000
arm label
Gemcitabine, Paclitaxel and Doxorubicin
regimen
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 minutes; Doxorubicin 40 mg/m\^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy.
analyzed count
32
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00478361-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-bavencio-ad600f37
nct id
NCT00478361
harm key
EG000
source section id
NCT00478361-ae
event group key
EG000
event group label
Gemcitabine, Paclitaxel and Doxorubicin
serious affected
39
serious at risk
39
other affected
34
other at risk
39
frequency threshold
0
collection period
Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
event definition
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice