NCT00478361 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-10-09

This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate

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outcome · POSTED

Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease

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outcome · POSTED

Safety and Efficacy of Same-day Pegfilgrastim

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder, urethra, or upper urinary tract * Mixed TCC and variant histologies (i.e., small cell, squamous cell, adenocarcinoma, or sarcoma) allowed if present in \< 50% of the biopsy specimen * Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution. * Measurable disease: may include radiographic detection of metastases in lymph nodes (\>= 1.5 cm) or liver or lung (\>= 1.0 cm) OR pelvic mass palpable on examination under anesthesia * Creatinine clearance \< 60 mL/min; no renal insufficiency that requires hemodialysis; no renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy) * Zubrod performance status 0-2 * Platelet count \> 100,000/mm\^3 * Absolute granulocyte count \> 1,500/mm\^3 * Bilirubin =\< 2.0 mg/dL * Aminotransferases (AST and ALT) =\< 2 times upper limit of normal * Left ventricular ejection fraction (LVEF) \> 40% OR normal electrocardiogram (EKG or ECG) and no history of cardiac disease * All patients must be evaluated in the Department of Genitourinary Medical Oncology at M. D. Anderson Cancer Center or participating CCOP center prior to signing informed consent. * No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy * Prior intravesicular chemotherapy allowed Exclusion Criteria: * No brain metastases * Not pregnant or nursing * No severe or uncontrolled infection * No New York Heart Association class III-IV congestive heart failure, unstable angina, or history of myocardial infarction within the past 6 months * No peripheral neuropathy \>= grade 2 * No persistently uncontrolled diabetes mellitus * No chronic liver disease * No HIV positivity * No other malignancy except nonmelanoma skin cancer unless disease-free for the past 3 years * No overt psychosis, mental disability, or other condition that would preclude giving informed consent * No known sickle cell disease * No uncontrolled severe hypertension * Renal insufficiency that requires hemodialysis or renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy).
healthy Volunteers: false
sex: ALL
std Ages: CHILD
ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Paclitaxel 135 mg/m\^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m\^2 IV over 90 min; Doxorubicin 40 mg/m\^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
intervention Names
Drug: Gemcitabine hydrochloride
Drug: Paclitaxel
Drug: Doxorubicin hydrochloride
Drug: Pegfilgrastim
label
Gemcitabine, Paclitaxel and Doxorubicin
type
EXPERIMENTAL

interventions

arm Group Labels
Gemcitabine, Paclitaxel and Doxorubicin
description
Gemcitabine 900 mg/m\^2 IV over 90 minutes repeat every 14 days.
name
Gemcitabine hydrochloride
other Names
dFdC
difluorodeoxycytidine hydrochloride
gemcitabine
Gemzar
type
DRUG
arm Group Labels
Gemcitabine, Paclitaxel and Doxorubicin
description
135 mg/m\^2 IV over 1 hour
name
Paclitaxel
other Names
Anzatax
Asotax
TAX
Taxol
type
DRUG
arm Group Labels
Gemcitabine, Paclitaxel and Doxorubicin
description
Doxorubicin 40 mg/m\^2 IV over 20 minutes
name
Doxorubicin hydrochloride
other Names
ADM
ADR
Adria
Adriamycin PFS
Adriamycin RDF
type
DRUG
arm Group Labels
Gemcitabine, Paclitaxel and Doxorubicin
description
Subcutaneously injection on day 1.
name
Pegfilgrastim
other Names
Filgrastim SD-01
GCSF-SD01
Neulasta
SD-01 sustained duration G-CSF
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 40
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Objective Response Rate
time Frame
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.

secondary Outcomes

description
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.
measure
Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease
time Frame
Registration Date of each participant for up to three years or death whichever came first
description
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.
measure
Safety and Efficacy of Same-day Pegfilgrastim
time Frame
Up to 3 years

Full study description

brief Summary: This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
detailed Description: PRIMARY OBJECTIVES: I. Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency. SECONDARY OBJECTIVES: I. Assess the safety and tolerability of this regimen in these patients. II. Determine the median time to progression in patients treated with this regimen. III. Determine the median survival duration in patients treated with this regimen. IV. Assess the safety and efficacy of pegfilgrastim in these patients. OUTLINE: This is a multicenter study. Patients receive doxorubicin hydrochloride intravenous (IV) over 20 minutes, paclitaxel IV over 60 minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 3 years.

Source references