Gemcitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: docetaxel; gemcitabine hydrochloride
Intervention description: docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.; IV over 30 minutes on days 1 and 8 followed by docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Gemcitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel
      works in treating patients with metastatic prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Androgen-independent metastatic prostate cancer with evidence of clinical,
                  radiographic, or biochemical progression in the setting of castrate levels of
                  testosterone (< 50 mg/dL)

                    -  No androgen-independent prostate cancer with a rising prostate-specific
                       antigen (PSA) without clinical or radiographic evidence of metastases

               -  Clinical or radiographic evidence of metastatic disease with a rising PSA
                  measured 2 times at ≥ 1 week interval allowed

          -  Antiandrogen therapy must have been stopped at least 4 weeks (for flutamide) or 6
             weeks (for bicalutamide or nilutamide) prior to study entry with evidence of either a
             rising PSA (from baseline) measured twice at least 2 weeks apart or radiographic
             evidence of disease progression

          -  Testicular androgen suppression (< 50 mg/dL) must be maintained with either
             luteinizing-hormone releasing-hormone (LHRH) therapy or bilateral orchiectomy

          -  No clinical evidence of CNS metastases

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1.5 mg/dL

          -  AST and ALT ≤ 2 times normal

          -  Creatinine < 2 mg/dL

          -  No history of severe uncontrolled congestive heart failure (CHF), ventricular
             dysrhythmias, or severe cardiovascular disease (American Heart Association class III
             or IV)

          -  Disease-free of prior malignancies for ≥ 5 years, with the exception of curatively
             treated basal cell or squamous cell carcinoma of the skin or low-grade, low-stage
             bladder cancer

          -  No active infection or parenteral antibiotics within 7 days of study entry

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No radiation therapy within 4 weeks prior to study entry

          -  No filgrastim (G-CSF) within 24 hours before or after study therapy

          -  No prior systemic chemotherapy for metastatic disease

               -  Neoadjuvant or adjuvant non-taxane chemotherapy more than 1 year prior to study
                  entry allowed

          -  No concurrent local radiotherapy for control of pain or life-threatening situations