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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Patients With Prostate Cancer  Chemotherapy in Treating Patients With Prostate Cancer
Chemotherapy in Treating Patients With Prostate Cancer
For Condition: recurrent prostate cancer,stage 4 prostate cancer
Status: Completed
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DX-8951f in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: I. Determine the antitumor activity of DX-8951f as measured by PSA response in patients with hormone refractory prostate cancer. II. Determine the antitumor activity of this drug in the subpopulation of these patients with measurable disease. III. Evaluate the quantitative and qualitative toxicities of this drug in these patients. IV. Evaluate the pharmacokinetics of this drug in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for 5 days. Courses repeat every 21 days. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients with no evidence of PSA decrease by the start of course 3 receive no further treatment. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed prostate carcinoma - Metastatic disease - Documented progression of prostate cancer while receiving androgen ablative therapy (i.e., surgical or chemical castration and a serum testosterone level in the castrate range) - Documented hormone therapy resistance defined as: PSA rise on 3 occasions not less than 4 weeks apart; Any evidence of progressive measurable disease; PSA must be above 20 ng/mL prior to study entry - No brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No prophylactic colony stimulating factors to prevent neutropenia; No concurrent biologic therapy - Chemotherapy: No more than 1 prior cytotoxic chemotherapy regimen; No concurrent cytotoxic chemotherapy - Endocrine therapy: See Disease Characteristics; At least 6 weeks since prior peripheral antiandrogens (e.g., flutamide); No concurrent steroid therapy initiated within past 2 months; Current LHRH agonist therapy should continue through study - Radiotherapy: At least 4 weeks since prior radiotherapy (except low dose, non myelosuppressive) and recovered; No prior irradiation to greater than 25% of bone marrow; No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium; No concurrent radiotherapy - Surgery: See Disease Characteristics; At least 4 weeks since prior major surgery and recovered; No concurrent surgery - Other: No other concurrent anticancer treatment; At least 28 days since investigational drugs, including analgesics or antiemetics; No other investigational drugs during and for 28 days after study; No concurrent drugs that induce or inhibit CYP3A enzyme; No concurrent herbal preparations (e.g., PC-SPES) --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Hemoglobin at least 9.0 g/dL; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT/SGPT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No active congestive heart failure; No uncontrolled angina; No myocardial infarction within the past 6 months - Other: Fertile patients must use effective contraception; No uncontrolled pain requiring irradiation; No concurrent serious infection; No other malignancy within the past 5 years except nonmelanoma skin cancer; No overt psychosis, mental disability, or incompetence
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
U.S. Oncology Research Inc.
Houston, Texas, 77060
United States
Institute for Drug Development
San Antonio, Texas, 78245-3217
United States
Additional Information:
Study ID Numbers: CDR0000067146; DAIICHI-8951A-PRT012,SACI-IDD-99-03,SLLH-BHS-99-0020
Study Start Date: June 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004045
Other Recurrent Prostate Cancer Studies:
1. Vaccine Therapy Plus Biological Therapy in Treating Patients With Prostate Cancer
2. Paclitaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
3. Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer
4. Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
5. Gene Mutations in Patients With Advanced Prostate Cancer That Is Not Responsive to Hormone Therapy
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Chemotherapy in Treating Patients With Prostate Cancer
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