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

• Status: Completed
• Trial end date: 2007-06-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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