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Bladder CancerPhase 2NCT00005086

Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer

A Phase 2 study testing cisplatin, docetaxel and gemcitabine hydrochloride in people with Bladder Cancer, run by University of Chicago at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IV locally advanced or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
cisplatin, docetaxel and gemcitabine hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
4 sitesUnited States
Study dates
Aug 1999to Apr 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV locally advanced or metastatic transitional cell carcinoma of the urothelium that is not amenable to curative surgery or radiotherapy
  • T4b or N2 or N3 or M1
  • No pure adenocarcinomas, pure squamous carcinomas, or small cell carcinoma
  • Evaluable or bidimensionally measurable disease If only single lesion, must not be within portal of prior irradiation
  • No active CNS metastases
  • Adequately treated CNS metastases eligible provided stable for 8 weeks following therapy and no longer requires steroids or antiseizure medication
  • No clinically significant pleural effusions or ascites unless drained prior to administration of methotrexate

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • CALGB 0-1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT less than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No uncontrolled cardiac disease (e.g., congestive heart failure, arrhythmia, or angina)

Pulmonary:

  • No uncontrolled pulmonary disease (e.g., chronic obstructive pulmonary disease)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No concurrent active infection
  • No known hypersensitivity to docetaxel, methotrexate, cisplatin, gemcitabine, filgrastim (G-CSF), oprevelkin, or any component of these products
  • No serious concurrent medical disorder
  • No medical or psychiatric conditions that would compromise consent or preclude completion of study
  • No other malignancy within the past 3 years except:
  • Carcinoma in situ of the cervix
  • Adequately treated nonmelanoma skin cancer
  • Stage I or II prostate cancer provided adequate local therapy (surgery or radiation) has been administered and PSA is less than 1.0 ng/mL
  • No preexisting peripheral neuropathy grade 2 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy for metastatic disease
  • At least 6 months since prior neoadjuvant or adjuvant chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • At least 3 weeks since prior major surgery and recovered

Other:

  • No other concurrent investigational drugs

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Louis A. Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46885-5099

  • Oncology/Hematology Associates of Central Illinois, P.C.

    Peoria, Illinois, 61602

Other trials in United States

About this study

Official title: A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IV locally advanced or metastatic bladder cancer.

Read the detailed description

OBJECTIVES:

  • Determine the response rate to the combination of docetaxel and methotrexate followed by gemcitabine and cisplatin in patients with stage IV locally advanced or metastatic, previously untreated, transitional cell carcinoma of the urothelium.
  • Assess the toxicities of this sequential regimen in this patient population.
  • Assess time to event efficacy measures including time to disease progression, duration of response, and overall survival in these patients treated with this sequential regimen.

OUTLINE: Patients receive methotrexate IV on days 1 and 8 and docetaxel IV over 1 hour on day 8 every 3 weeks for 9 weeks. Patients then receive cisplatin IV over 2 hours on day 1 and gemcitabine IV over 100 minutes on days 1 and 8 every 3 weeks for 9 weeks. This 18 week sequential regimen constitutes 1 full course. Treatment continues in the absence of unacceptable toxicity or disease progression.

Patients are followed until death or until 2 years after study entry, whichever comes first.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24 months.

Conditions
Bladder Cancer
Keywords
stage IV bladder cancer, transitional cell carcinoma of the bladder
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00005086
Study groupRoleWhat they receive
Arm AExperimentalMethotrexate will be given as a short infusion (introduced into a vein) for approximately 5 minutes on the first day (day 1). ). A week later (day 8), both methotrexate and docetaxel will be given the same way, but this will take about 1 hour. The first course of treatment consists of receiving treatment on day 1 and day 8 every 21 days for 9 weeks. X-rays or scans will then be performed to determine if your tumor is shrinking. You will then start treatment with gemcitabine and cisplatin. On the first day (day 1), you will receive both cisplatin and gemcitabine into your vein. A week later (day 8), you will receive only gemcitabine as an infusion into your vein over 100 minutes and no additional intravenous fluid will be required on that day. This second course of treatment consists of receiving treatment on day 1 and day 8 every 21 days for 9 weeks.
Receives: Drug: cisplatin; Drug: docetaxel; Drug: gemcitabine hydrochloride; Drug: methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2003 (estimated)
  2. Study startAug 1999
  3. Primary completionAug 2002
  4. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005086
Sponsor's protocol ID
11203
Other IDs
UCCRC-11203, NCI-G00-1733
Status last verified
Sep 2013
First submitted
6 Apr 2000
Last updated
5 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, docetaxel and gemcitabine hydrochloride in people with Bladder Cancer, run by University of Chicago at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2013.

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