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Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function

Primary Purpose

Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
paclitaxel
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium Mixed histologies containing a component of transitional cell carcinoma allowed Bidimensionally measurable disease No clinical evidence of CNS metastases Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 3.0 mg/dL Glomerular filtration rate no greater than 50 mL/min Cardiovascular: No history of American Heart Association class III or IV heart disease No uncontrolled congestive heart failure No severe cardiac arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception No preexisting peripheral neuropathy grade 2 or greater No active unresolved infection requiring parenteral antibiotics within the past 7 days No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy for advanced disease Prior intravesical BCG for superficial disease allowed Chemotherapy: Prior intravesical chemotherapy for superficial disease allowed No prior chemotherapy for advanced disease At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV), or cisplatin as a radiosensitizer Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Other: No concurrent hemodialysis

Sites / Locations

  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Kalamazoo
  • Veterans Affairs Medical Center - East Orange
  • Albert Einstein Clinical Cancer Center
  • James P. Wilmot Cancer Center
  • CCOP - Merit Care Hospital
  • Ireland Cancer Center
  • Cleveland Clinic Taussig Cancer Center
  • University of Pennsylvania Cancer Center
  • Fox Chase Cancer Center
  • CCOP - Sioux Community Cancer Consortium
  • CCOP - Scott and White Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • CCOP - Marshfield Medical Research and Education Foundation
  • Medical College of Wisconsin
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 2, 2000
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005644
Brief Title
Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function
Official Title
Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2001 (Actual)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
June 15, 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

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 cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced cancer of the urothelium with decreased kidney function.
Detailed Description
OBJECTIVES: Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium with renal insufficiency when treated with paclitaxel and gemcitabine. Determine the toxicity of this regimen in this patient population. OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment continues every 4 weeks for a minimum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for this study within 10-27 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Keywords
stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer, urethral cancer associated with invasive bladder cancer, metastatic transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed progressive regional or metastatic transitional cell carcinoma of the urothelium Mixed histologies containing a component of transitional cell carcinoma allowed Bidimensionally measurable disease No clinical evidence of CNS metastases Clinically unsuspected organ-confined prostate cancer found at time of cystoprostatectomy allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times upper limit of normal (ULN) and alkaline phosphatase normal OR Alkaline phosphatase no greater than 4 times ULN and SGOT normal OR SGOT less than 1.5 times ULN and alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 3.0 mg/dL Glomerular filtration rate no greater than 50 mL/min Cardiovascular: No history of American Heart Association class III or IV heart disease No uncontrolled congestive heart failure No severe cardiac arrhythmias Other: Not pregnant or nursing Fertile patients must use effective contraception No preexisting peripheral neuropathy grade 2 or greater No active unresolved infection requiring parenteral antibiotics within the past 7 days No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior systemic biologic response modifier therapy for advanced disease Prior intravesical BCG for superficial disease allowed Chemotherapy: Prior intravesical chemotherapy for superficial disease allowed No prior chemotherapy for advanced disease At least 6 months since prior adjuvant/neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or cisplatin, methotrexate, and vinblastine (CMV), or cisplatin as a radiosensitizer Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery and recovered Other: No concurrent hemodialysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Vaughn, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07019
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
CCOP - Marshfield Medical Research and Education Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium and Decreased Kidney Function

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