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

Bladder Cancer Clinical Trial

Official title:

Phase II Trial of Paclitaxel Plus Gemcitabine in Patients With Advanced Urothelial Carcinoma With Renal Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005644
• Other study ID #: CDR0000067810
• Secondary ID: E-5899
• Status: Completed
• Phase: Phase 2
• Start date: January 2, 2001
• Est. completion date: June 15, 2007

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 15, 2007
• Est. primary completion date: February 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Kidney Neoplasms
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Ureteral Neoplasms
• Urethral Cancer
• Urethral Neoplasms
• Urinary Bladder Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
United States	Albert Einstein Clinical Cancer Center	Bronx	New York
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	CCOP - Merit Care Hospital	Fargo	North Dakota
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	James P. Wilmot Cancer Center	Rochester	New York
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Scott and White Hospital	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,