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Home > "P" Clinical Trials Conditions > Perifosine in Treating Patients With Recurrent Prostate Cancer  Perifosine in Treating Patients With Recurrent Prostate Cancer
Perifosine in Treating Patients With Recurrent Prostate Cancer
For Condition: recurrent prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): California Cancer Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have recurrentprostate cancer.
Details: OBJECTIVES: - Determine the prostate-specific antigen (PSA) response to perifosine in patients with hormone-sensitive prostate cancer who have a biochemical recurrence after prior local curative therapy. - Compare the 6-month increase in PSA levels with baseline in patients treated with this drug. - Determine the PSA doubling time and time to PSA progression in patients treated with this drug. - Determine the qualitative and quantitative toxic effects of this drug in these patients. - Identify potential molecular markers predictive of decreased PSA doubling time and, possibly, PSA response in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy with or without brachytherapy vs surgery and radiotherapy) and original combined Gleason score (7 or less vs 8-10). Patients receive oral perifosine once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the prostate - Biochemical recurrence - Rising prostate-specific antigen (PSA) of at least 2.0 ng/mL following a nadir after local curative therapy (radical prostatectomy and/or pelvic radiotherapy) - Rising PSA must be confirmed by 2 consecutive increases measured at least 2 weeks apart - No evidence of local or distant relapse by physical exam or radiography - No clinical or radiographic evidence of metastatic disease by all of the following: - CT scan or MRI of the pelvis - Bone scan - Posterior, anterior, and lateral x-ray PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Fertile patients must use effective contraception - No history of allergic reactions attributed to compounds of similar chemical or biological composition to perifosine - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or adequately treated stage I or II cancer currently in complete remission - No ongoing or active infection - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - At least 6 months since prior vaccine therapy - No concurrent biological response modifiers Chemotherapy - No prior cytotoxic chemotherapy - No other concurrent chemotherapy Endocrine therapy - Prior adjuvant or neoadjuvant hormonal therapy allowed provided treatment duration was no longer than 9 months* - At least 1 year since prior neoadjuvant or adjuvant androgen deprivation therapy* - No concurrent corticosteroids - No concurrent hormonal therapy NOTE: *No rising PSA at the time therapy was discontinued Radiotherapy - See Disease Characteristics - No concurrent radiotherapy Surgery - See Disease Characteristics Other - No other concurrent investigational agents - No other concurrent anticancer agents or therapies (investigational or commercial) - No concurrent complementary or alternative therapy (e.g., Hypericum perforatum [St. John's Wort], PC-SPES, or any other herbal remedy for the treatment of prostate cancer) - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PrimoLara, Study Chair, University of California Davis Cancer Center
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Przemyslaw Twardowski 626-359-8111ext 62307
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting David Quinn 323-865-0456
University of California Davis Cancer Center *Recruiting*
Sacramento, California, 95817
United States
Recruiting Frederick Meyers 916-734-8596
City of Hope Medical Group *Recruiting*
Pasadena, California, 91105
United States
Recruiting Mark McNamara 626-396-2900
Additional Information:
Study ID Numbers: CDR0000287195; NCI-5978,CHNMC-PHII-44-02166,CCC-PHII-44
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058214
Other Adenocarcinoma Of The Prostate Studies:
1. APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
2. Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer
3. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
4. Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
5. Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other California Clinical Trials
Other Pasadena Clinical Trials
Perifosine in Treating Patients With Recurrent Prostate Cancer
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