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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005086
Recruitment Status : Completed
First Posted : May 16, 2003
Last Update Posted : September 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Brief 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 metastatic bladder cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: methotrexate Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer
Study Start Date : August 1999
Actual Primary Completion Date : August 2002
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Arm A
Methotrexate 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.
Drug: cisplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: methotrexate

Primary Outcome Measures :
  1. Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • CALGB 0-1

Life expectancy:

  • At least 12 weeks


  • 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)


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


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


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


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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • See Disease Characteristics
  • No concurrent radiotherapy


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


  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005086

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61602
United States, Indiana
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, United States, 46885-5099
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago

Responsible Party: University of Chicago Identifier: NCT00005086     History of Changes
Other Study ID Numbers: 11203
First Posted: May 16, 2003    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
stage IV bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Folic Acid Antagonists
Antirheumatic Agents