Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer

• Status: Completed
• Trial end date: 2005-04-01
• 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 tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IV locally advanced or metastatic bladder cancer.

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

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Docetaxel; Gemcitabine; Methotrexate

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV locally advanced or metastatic transitional cell carcinoma of the urothelium that is not amenable to curative surgery or radiotherapy

• T4b or N2 or N3 or M1

• No pure adenocarcinomas, pure squamous carcinomas, or small cell carcinoma

• Evaluable or bidimensionally measurable disease If only single lesion, must not be within portal of prior irradiation

• No active CNS metastases

• Adequately treated CNS metastases eligible provided stable for 8 weeks following therapy and no longer requires steroids or antiseizure medication

• No clinically significant pleural effusions or ascites unless drained prior to administration of methotrexate

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• CALGB 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

• Bilirubin less than 1.5 mg/dL

• SGOT less than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No uncontrolled cardiac disease (e.g., congestive heart failure, arrhythmia, or angina)

Pulmonary:

• No uncontrolled pulmonary disease (e.g., chronic obstructive pulmonary disease)

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No concurrent active infection

• No known hypersensitivity to docetaxel, methotrexate, cisplatin, gemcitabine, filgrastim (G-CSF), oprevelkin, or any component of these products

• No serious concurrent medical disorder

• No medical or psychiatric conditions that would compromise consent or preclude completion of study

• No other malignancy within the past 3 years except:

• Carcinoma in situ of the cervix

• Adequately treated nonmelanoma skin cancer

• Stage I or II prostate cancer provided adequate local therapy (surgery or radiation) has been administered and PSA is less than 1.0 ng/mL

• No preexisting peripheral neuropathy grade 2 or greater

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy for metastatic disease

• At least 6 months since prior neoadjuvant or adjuvant chemotherapy

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent steroids

Radiotherapy:

• See Disease Characteristics

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

• At least 3 weeks since prior major surgery and recovered

Other:

• No other concurrent investigational drugs