Overview

Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

Status:
Completed
Trial end date:
2003-04-01
Target enrollment:
0
Participant gender:
Male
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 I/II trial to study the effectiveness of combination chemotherapy consisting of estramustine, paclitaxel, and carboplatin in treating patients with advanced prostate cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Estramustine
Goserelin
Leuprolide
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically proven prostate cancer that is androgen dependent
or independent Androgen dependent disease must meet ONE OR MORE of the following criteria:
(1) Previously untreated, locally advanced adenocarcinoma of the prostate and: T1-2 tumor
stage, PSA greater than 20 ng/mL OR T3-4 tumor stage OR Gleason grade 8-10 (2) Small cell
carcinoma, poorly differentiated tumor with neuroendocrine features, or neuroendocrine
carcinoma of any stage (3) Disease metastatic to bones or soft tissues (visceral or lymph
nodes) that is evaluable on MRI, CT, or bone scan (patients with evaluable disease that
relapsed after neoadjuvant hormone therapy prior to radical prostatectomy or radiotherapy
are eligible) Patients meeting one of the above criteria who have started on an
antiandrogen (flutamide, nilutamide, or bicalutamide) and/or a gonadotropin releasing
hormone (GnRH) analog (luprolide or goserelin) are eligible if they have been on androgen
ablation (GnRH analog with or without antiandrogen) for no more than 3 months Androgen
independent disease must meet ALL of the following criteria: (1) Disease progression
despite primary hormone treatment (e.g., orchiectomy, estrogen therapy, GnRH analog with or
without an antiandrogen), OR disease progression despite receiving antiandrogen treatment
as part of primary hormone therapy, evidenced by: Bone (new osseous lesion) or Soft tissue
(greater than 25% increase in bidimensionally measurable disease) or Rising PSA (on any 3
determinations taken at weekly intervals (at least) to greater than 50% above the patient's
baseline PSA value) despite castrate (no greater than 30 ng/mL) levels of testosterone (2)
At least 2 weeks since change in hormone therapy (including prednisone or dexamethasone)
(3) Continuation on treatments to maintain castrate levels of testosterone if no prior
orchiectomy (4) Evaluable or measurable disease (5) No more than 1 prior course of
chemotherapy (6) No more than 1 prior course of palliative radiotherapy or radioisotope
treatment (strontium chloride Sr 89)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
120,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL or
1.5 times upper limit of normal (ULN) AST no greater than 56 U/L or 1.5 times ULN Renal:
Creatinine no greater than 2.0 mg/dL or 1.5 times ULN Cardiovascular: At least 6 months
since acute deep vein thrombosis and/or pulmonary embolism No serious ventricular
arrhythmia No significant heart disease No active angina (stable or unstable) No myocardial
infarction within 6 months No congestive heart failure No transient ischemic attack or
stroke within 6 months Neurologic: No grade 3-4 peripheral neuropathy Other: No severe
infection No severe malnutrition No other serious medical illnesses

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since immunotherapy
Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy No other
concurrent chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See
Disease Characteristics At least 4 weeks since radiotherapy (8 weeks if systemic
radioisotope treatment with strontium chloride Sr 89) No concurrent radiation of the only
measurable lesion No concurrent radiotherapy or radioisotope therapy Surgery: See Disease
Characteristics At least 4 weeks since major surgery No concurrent surgery to the only
measurable lesion Other: Permanent venous access device (e.g., mediport or Hickman
catheter) required