A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer

Inclusion 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