Overview
Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
Male
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 trial to study the effectiveness of combining estramustine and paclitaxel in treating patients who have prostate cancer that has not responded to hormone therapy.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
New York University School of Medicine
NYU Langone HealthCollaborator:
National Cancer Institute (NCI)Treatments:
Albumin-Bound Paclitaxel
Estramustine
Hormones
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate withprogressive systemic disease despite at least 1 endocrine manipulation including 1 of the
following: Orchiectomy LHRH analogue with or without flutamide, megestrol, or
diethylstilbestrol Flutamide must be discontinued for at least 2 weeks with PSA stabilized
above normal or rising Measurable or evaluable disease No brain metastasis
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Greater than 2 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin greater than 1 mg/dL SGOT greater than 2 times upper
limit of normal Renal: Creatinine less than 2 mg/dL Hydronephrosis with impaired renal
function must be decompressed adequately Cardiovascular: No severe cardiac (i.e.,
symptomatic arrhythmia requiring medication or active congestive heart failure) or coronary
disease that are unstable despite medication Other: Adequate nutritional status (at least
1,500 Kcal/day) No other significant active medical illness that would preclude study
therapy or survival No other malignancy within the past 5 years except adequately treated
basal or squamous cell carcinoma of the skin No acute spinal cord compression
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers
Chemotherapy: No other concurrent chemotherapy Endocrine therapy: See Disease
Characteristics At least 2 weeks since prior corticosteroids No concurrent exogenous
corticosteroids except for documented CNS metastases or adrenal insufficiency Concurrent
hormones for nondisease conditions allowed (e.g., insulin for diabetes mellitus) Concurrent
continuation of monthly hormonal therapy with an LHRH agonist or DES required Radiotherapy:
Prior radiation to symptomatic metastatic site allowed provided it is not the only
measurable or evaluable lesion At least 2 weeks since prior radiotherapy and recovered No
concurrent radiotherapy No concurrent palliative radiotherapy except for whole brain
irradiation for documented CNS disease or impending spinal cord compression Surgery: See
Disease Characteristics At least 3 weeks since prior surgery and recovered Other: No other
concurrent treatment for prostate cancer except pain palliation