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COMPLETEDPHASE2

Study of Bortezomib and Docetaxel for Patients With Hormone Refractory Prostate Cancer

A Phase II Study of Bortezomib (Velcade®, PS-341) and Docetaxel for Patients With Hormone Refractory Prostate Cancer

NCT00183937•University of Southern California

Summary

This study is for patients who have been treated with surgical removal of the testes or hormone therapy (Lupron or Zoladex) and whose prostate cancer has worsened despite this treatment. PS 341 is a type of drug known as a "proteasome inhibitor." By inhibiting the "proteasome" in cancer cells, PS-341 alters the way those cells divide). We hope to learn whether this combination chemotherapy decreases cancer symptoms and tests (prostate specific antigen, also called PSA), and to determine how frequently serious side effects might occur with this treatment for this stage of prostate cancer.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patient must have had a histological or cytological diagnosis of adenocarcinoma of prostate and currently must have metastatic disease (stage TxNxM1) that is unresponsive or refractory to hormone therapy. Patients must have metastatic prostate cancer deemed to be hormone refractory by one or more of the following (despite androgen ablation and anti-androgen withdrawal where applicable):
•Progression of measurable disease assessed within 28 days prior to registration. OR
•Progression of non-measurable (i.e. bone scan or PET scan) disease assessed within 42 days prior to registration. AND
•Rising PSA - defined as at least 2 consecutive rises in PSA documented over a reference value (measure 1). The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater then the second measure and it must be obtained at least 7 days after the 2nd measure. Patient must have a PSA concentration of at least 5 ng/ml in addition to increasing PSA to be eligible Note: The PSA result (done within 28 days prior to registration) need not be elevated for inclusion provided other criteria for progression are met and the serum PSA is at least 2 ng/ml.
•Must have received prior hormonal therapy and have a castrate level of testosterone (less than 100ng/ml within 90 days of entry to the study). Patients treated with orchiectomy are eligible. If patients have been treated with non-steroidal anti-androgens, the patients must have ceased taking flutamide or nilutamide at least 28 days prior to enrollment and at least 42 days prior to enrollment for biclutamide. Either method of castration can have been supplemented with nonsteroidal antiandrogen (e.g. flutamide, biclutamide, nilutamide). Patients may have been treated with "second-line" hormonal therapy such as ketoconazole, aminoglutethimide and/or estrogen therapies but these must have ceased at least 7 days prior to commencement of study therapy.
•May have received at most one prior chemotherapy for hormone refractory prostate cancer provided they have not received docetaxel or Bortezomib for that indication or otherwise within 2 years of trial entry.
•Prior radiation therapy is allowed but it must have been to less than 25% of total body bone marrow. This includes prior use of samarium, but patients can not have received strontium. (\>10 days must have elapsed since completion of RT with recovery from side effects. Soft tissue disease irradiated in the prior 2 months is not and may not be designated as measurable
•Creatinine less than or equal to 1.5x the institutional upper limit of normal (within 28 days prior to registration)
•Hepatic function Total Bilirubin less than or equal to ULN AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
•In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
+8 more criteria

Exclusion Criteria

•Myocardial infarction or angina pectoris within one year of registration
•History of brain metastases, treated or untreated. (Patients with neurological symptoms must have CT or MRI brain negative for metastatic disease within 56 days prior to registration). Patients who have recovered from spinal cord compression and are clinical stable may enter the study provided they fulfill other criteria.
•Not recovered from major infections and/or surgical procedures, or has significant active concurrent other medical illness precluding protocol therapy or survival.
•Known or anticipated severe hypersensitivity reaction to bortezomib, boron, mannitol, docetaxel or polysorbate 80.
•Other prior malignancy (except patients who have had another stage I or II malignancy currently in complete remission or other cancer with no evidence of disease for greater than 5 years from accrual to the current trial. Patients with basal or squamous cell carcinoma of the skin that have been treated with curative intent can be accrued to this trial 30 days after treatment. Solar keratoses treated topically do not preclude entry).
•Patient has greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment.
•Prior therapy with docetaxel or paclitaxel
•Prior treatment with more than one prior chemotherapy for hormone refractory prostate cancer.
•Ongoing therapy with drugs known to inhibit P4503A4 drug metabolism including:
•Macrolide antibiotics: erythromycin, troleandomycin, azithromycin Imidazole antifungal agents: ketoconazole, itraconazole, fluconazole HIV protease inhibitors Immunosuppressive agents: cyclosporin, FK-506
+1 more criteria

Locations (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

April 30, 2005

Primary Completion Date

October 23, 2010

Completion Date

June 11, 2012

Last Updated

May 14, 2018

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

PS 341

DRUG

Docetaxel

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Bortezomib and Docetaxel for Patients With Hormone Refractory Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

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Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC