Status:
TERMINATED
Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Lead Sponsor:
Medical University of South Carolina
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as epirubicin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill mor...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Meets 1 of the following criteria:
- Measurable disease with any prostate-specific antigen (PSA) value
- Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Histologic confirmation required if measurable disease is confined to a solitary lesion
- Non-measurable disease with PSA ≥ 5 ng/mL\*
- The following are considered non-measurable disease:
- Bone lesions
- Pleural or pericardial effusion
- Ascites
- CNS lesions
- Leptomeningeal disease
- Irradiated lesions unless disease progression was documented after prior radiotherapy NOTE: \*Patients with PSA ≥ 5 ng/mL only are not eligible
- Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria:
- Objective evidence of increase \> 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
- One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL
- Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart)
- Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy
- Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues)
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Meets 1 of the following criteria:
- AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
- AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
- AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
- Bilirubin normal
- Renal
- Creatinine ≤ 1.5 times ULN
- Cardiovascular
- No uncontrolled high blood pressure
- No unstable angina
- No symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No serious uncontrolled cardiac arrhythmia
- No New York Heart Association class III or IV heart disease
- Other
- Fertile patients must use effective contraception during and for at least 3 months after study participation
- No peripheral neuropathy ≥ grade 2
- No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- Chemotherapy
- No prior chemotherapy, including estramustine or suramin for prostate cancer
- No other concurrent chemotherapy
- Endocrine therapy
- See Disease Characteristics
- At least 4 weeks since prior antiandrogen therapy
- No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
- Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- 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 surgery and recovered
Exclusion
Key Trial Info
Start Date :
June 8 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00096304
Start Date
June 8 2004
End Date
November 30 2007
Last Update
April 10 2018
Active Locations (1)
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1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425