Skip to content
Triangle logo TriangleGet started
← Imfinzi: metastatic Urothelial carcinoma (neoadjuvant) after prior therapy

NCT00942331 · STUDY IN CONTEXT

Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

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

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.

Intent to treat (ITT) analysis population

→

secondary · POSTED

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.

Source null

→

secondary · POSTED

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.

All patients registered, eligible and assessed for a response are included in this analysis.

→

secondary · POSTED

The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below.

Patients who started treatment are evaluable for adverse events.

→

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

FACT · Overall Survival (OS)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT00942331
qol key
qol-0000
source section id
NCT00942331-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Overall Survival (OS)
measure definition
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.
time frame
From date of randomization to date of death due to any cause, assessed up to 7 years
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Intent to treat (ITT) analysis population
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Progression-free Survival (PFS)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT00942331
qol key
qol-0001
source section id
NCT00942331-om-0001
source outcome index
1
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Progression-free Survival (PFS)
measure definition
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.
time frame
From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-urothelial-carcinoma-imfinzi-92d35647
nct id
NCT00942331
trial label
Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
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
4
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0000
    source section id
    NCT00942331-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    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.
    time origin
    From date of randomization to date of death due to any cause, assessed up to 7 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent to treat (ITT) analysis population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0001
    source section id
    NCT00942331-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    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.
    time origin
    From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0002
    source section id
    NCT00942331-om-0002
    source outcome index
    2
    endpoint
    Objective Response
    endpoint definition
    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.
    time origin
    Up to 7 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All patients registered, eligible and assessed for a response are included in this analysis.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0003
    source section id
    NCT00942331-om-0003
    source outcome index
    3
    endpoint
    Number of Patients Experiencing Grade 3+ Toxicity
    endpoint definition
    The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below.
    time origin
    Up to 7 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who started treatment are evaluable for adverse events.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm II (GCB)
    regimen
    Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm I (GCP)
    regimen
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    254
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm II (GCB)
    regimen
    Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    252
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm I (GCP)
    regimen
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    254
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm II (GCB)
    regimen
    Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    213
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm I (GCP)
    regimen
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    209
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm II (GCB)
    regimen
    Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    237
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm I (GCP)
    regimen
    Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
    analyzed count
    232
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00942331-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    harm key
    EG000
    source section id
    NCT00942331-ae
    event group key
    EG000
    event group label
    Arm II (GCB)
    serious affected
    95
    serious at risk
    237
    other affected
    215
    other at risk
    237
    frequency threshold
    0
    collection period
    Up to 7 years
    event definition
    All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    harm key
    EG001
    source section id
    NCT00942331-ae
    event group key
    EG001
    event group label
    Arm I (GCP)
    serious affected
    87
    serious at risk
    232
    other affected
    205
    other at risk
    232
    frequency threshold
    0
    collection period
    Up to 7 years
    event definition
    All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    qol key
    qol-0000
    source section id
    NCT00942331-om-0000
    source outcome index
    0
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Overall Survival (OS)
    measure definition
    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.
    time frame
    From date of randomization to date of death due to any cause, assessed up to 7 years
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Intent to treat (ITT) analysis population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-urothelial-carcinoma-imfinzi-92d35647
    nct id
    NCT00942331
    qol key
    qol-0001
    source section id
    NCT00942331-om-0001
    source outcome index
    1
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Progression-free Survival (PFS)
    measure definition
    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.
    time frame
    From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice