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

NCT ID: NCT00005644

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-02
• Study Completion Date: 2007-06-15

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

David J. Vaughn, MD

Role: STUDY_CHAIR

Abramson Cancer Center at Penn Medicine

Locations

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, United States

CCOP - Kalamazoo

Kalamazoo, Michigan, United States

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

James P. Wilmot Cancer Center

Rochester, New York, United States

Albert Einstein Clinical Cancer Center

The Bronx, New York, United States

CCOP - Merit Care Hospital

Fargo, North Dakota, United States

Ireland Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, United States

CCOP - Scott and White Hospital

Temple, Texas, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 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

Countries

United States

Other Identifiers

E-5899

Identifier Type: -

Identifier Source: secondary_id

CDR0000067810

Identifier Type: -

Identifier Source: org_study_id