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

NCT00005644 | Completed Phase 2

• 2 other identifiers: CDR0000067810E-5899
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 16

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.

Conditions

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

Interventions

gemcitabine hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, 07019, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

CCOP - Marshfield Medical Research and Education Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3596, United States

Location

Veterans Affairs Medical Center - Milwaukee (Zablocki)

Milwaukee, Wisconsin, 53295, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urethral Neoplasms

Interventions

Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urethral Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• David J. Vaughn, MD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 2, 2000
• First Posted: January 27, 2003
• Study Start: January 2, 2001
• Primary Completion: February 1, 2003
• Study Completion: June 15, 2007
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (16)