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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
docetaxel
gemcitabine hydrochloride
methotrexate
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage IV bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Louis A. Weiss Memorial Hospital
  • Oncology/Hematology Associates of Central Illinois, P.C.
  • Fort Wayne Medical Oncology and Hematology, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
September 4, 2013
Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005086
Brief Title
Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer
Official Title
A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage IV bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
methotrexate
Primary Outcome Measure Information:
Title
Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter M. Stadler, MD, FACP
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Louis A. Weiss Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Oncology/Hematology Associates of Central Illinois, P.C.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46885-5099
Country
United States

12. IPD Sharing Statement

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

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