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Home > "P" Clinical Trials Conditions > Phase I Study of Weekly Intravenous PS-341 Plus Mitoxantrone  Phase I Study of Weekly Intravenous PS-341 Plus Mitoxantrone
Phase I Study of Weekly Intravenous PS-341 Plus Mitoxantrone
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION: - Histologically confirmed or advanced metastatic AIPC, need anti-neoplastic Rx, continue LHRH analog Rx if it is the androgen suppression. Patients must discontinue anti-androgen Rx for >/= than 4 weeks (flutamide) or >/=6 weeks (bicalutamide & nilutamide). - Progressive measurable/evaluable disease, defined as: measurable disease RECIST, progressive bone metastasis, new lesion(s) on scan, progressive PSA, rising PSA by 2 measurements at least 1 wk apart & confirmed by 3rd or 4th. - Zubrod performance status of =/2. - Resting Left Ventricular Ejection Fraction (LEVF)=/>50%. - Labs within 14 days before first dose: ANC >/= 1,500/MM(3), Plt >/=100,000/mm(3), Hgb > 8.0 g/dL, T bili=/< 1.5 uln, ALT/AST =/< 2.5 ULN (if liver=/< 1.5 uln, ALT/AST =/< 2.5 ULN (if liver mets, equivalent to 180 mg/m2 of Doxorubicin cumulative dose. - Patients with diabetes mellitus requiring insulin, or those that have required pharmacologic intervention for diabetes mellitus for greater than 5 year. - Patient has uncontrolled brain metastases or central nervous system. - Patient has =/> Grade 2 peripheral neuropathy - Patient has an uncontrolled intercurrent illness (e.g., active infection) - Other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the patient's ability to provide informed consent or with the completion of treatment according to this protocol.
Total Enrollment: 42
Location and Contact Information:
M.D.Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Arlene Siefker-Radke 713-792-2830
Additional Information:
Study ID Numbers: ID02-227;
Study Start Date: March 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059631
Other Prostate Cancer Studies:
1. Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
2. Phase I Study of Weekly Intravenous PS-341 Plus Mitoxantrone
3. Suberoylanilide Hydroxamic Acid in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
4. Selenium and Vitamin E Cancer Prevention Trial (SELECT)
5. Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis
Related Studies:
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Phase I Study of Weekly Intravenous PS-341 Plus Mitoxantrone
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