combination chemotherapy plus filgrastim in treating patients with stage iv prostate cancer that has not responded to hormone therapy

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage iv prostate cancer that has not responded to hormone therapy.

objectives: i. determine the response rate (objective and psa response) and duration of response to estramustine, docetaxel, and carboplatin with filgrastim (g-csf) support in patients with hormone refractory prostate cancer. ii. determine the toxicity of this regimen in this patient population.

Eligibility criteria:
disease characteristics: histologically confirmed stage iv adenocarcinoma of the prostate failure on standard hormone therapy measurable disease with any psa accurately measured in at least 1 dimension as at least 20 mm by physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung or those lesions measured as at least 10 mm by spiral ct scan or nonmeasurable disease with psa at least 5 ng/ml nontarget lesions including small lesions with longest diameter less than 20 mm by conventional techniques or less than 10 mm by spiral ct scan and truly nonmeasurable lesions including: bone lesions pleural or pericardial effusions ascites cns lesions leptomeningeal disease irradiated lesions unless progression documented after radiotherapy documented progressive systemic disease despite at least 1 endocrine manipulation with either orchiectomy or lhrh agonist (which must be continued), or diethylstilbestrol for measurable disease: objective evidence of increase of greater than 20% in the sum of the longest diameters of target lesions from the time of maximal regression or the appearance of 1 or more new lesions for nonmeasurable disease: if bone only disease, appearance of 1 new lesion on bone scan attributable to prostate cancer along with a psa of at least 5 ng/ml or an elevated psa (at least 5 ng/ml) that has risen serially from baseline on 2 occasions each at least 1 week apart testosterone no greater than 50 ng/ml if no prior bilateral orchiectomy patient characteristics: age: 18 to 99 performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.0 times upper limit of normal (uln) ast no greater than 1.5 times uln renal: creatinine no greater than 1.5 times uln cardiovascular: no myocardial infarction or significant change in anginal pattern within past 1 year no congestive heart failure no new york heart association class ii-iv heart disease no deep venous thrombosis or pulmonary embolus within past 1 year other: fertile patients must use effective contraception no clinically significant peripheral neuropathy no known hypersensitivity to e. coli derived products prior concurrent therapy: biologic therapy: no concurrent sargramostim (gm-csf) chemotherapy: no prior chemotherapy no prior estramustine or suramin no other concurrent chemotherapy endocrine therapy: see disease characteristics at least 4 weeks since prior antiandrogens primary testicular androgen suppression (e.g., with an lhrh analogue) should not be discontinued concurrent lhrh analogue allowed if no prior bilateral orchiectomy radiotherapy: see disease characteristics at least 4 weeks since prior radiation and recovered at least 8 weeks since prior strontium chloride sr 89 or samarium sm 153 lexidronam pentasodium no concurrent palliative radiotherapy surgery: see disease characteristics at least 4 weeks since prior major surgery and recovered

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer