View Trial - USC/Norris Cancer Center Clinical Trials

Details for trial 4P-04-3

Description:	A Phase II Study of PS-341 (Velcade, Bortezomib) and Docetaxel for Patients with Hormone-Refractory Prostate Cancer.
Status:	Open
Randomized?	No

Researchers

Principal Investigator	Title
David Quinn	M.D.

Data Management

Name	Title
Charlean Ketchens	R.N.
Lagrimas Ilagan	D.M.
Jolie Solomon	R.N.
Francisco Acosta	D.M.

You may participate in this study if:

	Requirement
1	Histologic or cytologic diagnosis of adenocarcinoma of prostate and currently has metastatic disease (stage Tx Nx M1) that is unresponsive or refractory to hormone therapy. Must have metastatic prostate cancer deemed hormone-refractory by one or more of the following (despite androgen ablation and anti-androgen withdrawal where applicable): [a] Progression of measurable disease assessed within 28 days prior to registration, or [b] progression of non-measurable (i.e., bone scan or PET scan) disease assessed within 42 days prior to registration, and [c] 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 than 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.
2	Must have received prior hormonal therapy and have a castrate level of testosterone (<100 ng/ml within 90 days of study entry). Patients treated with orchiectomy are eligible. If patient has been treated with non-steroidal anti-androgens, patient 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 non-steroidal anti-androgen (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 treatment.
3	May have received at most 1 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.
4	Prior RT allowed but it must have been to <25% of total body BM. 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 disease).
5	ECOG PS 0-3. (For patients with PS 3, cause must be due to pain secondary to bone mets to be eligible).
6	AGC at least 1.5; Hgb at least 8.0; platelets at least 100,000 (within 14 days prior to registration).
7	Total bilirubin less than or equal to uln, SGOT, SGPT, and alk phos within range for eligibility. (See table).
8	Creatinine less than or equal to 1.5 x uln (within 28 days prior to registration).
9	Patients should (for good medical practice) have stabilization of their analgesic medications for at least 1 week prior to receiving study medication.
10	No other chemotherapy, BRMs, RT, radioisotope therapy (e.g., samarium or strontium), corticosteroid, or concomitant hormonal therapy may be given during protocol treatment.
11	Bisphosphonate therapy is permitted provided it commences prior to study entry and is maintained at recommended dosing intervals.
12	Completed baseline McGill Pain Questionnaire and Pain Medication Log prior to registration. The nurse or CRA must complete MPQ and PML cover sheet for baseline assessment prior to registration. If unable to complete questionnaires in English or Spanish, patient can be registered without contributing to QOL study).
13	Men of childbearing potential must be willing to use effective contraception while on therapy and for a reasonable period (90 days) thereafter.
14	Signed informed consent (including HIPAA authorization).

You may not participate in this study if:

1	MI or angina pectoris within 1 year of registration.
2	History of brain metastases, treated or untreated. (Patients with neurological symptoms must have CT or MRI of brain negative for metastatic disease within 56 days prior to registration). Patients who have recovered from spinal cord compression and are clinically stable may enter the study provided they fulfill other criteria.
3	Not recovered from major infections and/or surgical procedures, or has other significant active concurrent medical illness precluding protocol therapy or survival.
4	Known or anticipated severe hypersensitivity reaction to bortezomib, boron, mannitol, docetaxel, or polysorbate 80.
5	Other prior malignancy, except patients who have had another stage I or II malignancy currently in CR or other cancer with no evidence of disease for >5 years from accrual to the current trial. Patients with basal or squamous cell skin cancer that have been treated with curative intent can be accrued to this trial 30 days after therapy. Solar keratoses treated topically do not preclude entry.
6	Gr 2 or greater peripheral neuropathy within 14 days before enrollment.
7	Prior therapy with docetaxel or paclitaxel.
8	Prior treatment with >1 prior chemotherapy for hormone-refractory prostate cancer.
9	Ongoing therapy with drugs known to inhibit P4503A4 drug metabolism including: (a) Macrolide antibiotics: erythromycin, troleandomycin, azithromycin; (b) Imidazole anti-fungal agents: ketoconazole, itraconazole, fluconazole; (c) HIV protease inhibitors; (d) Immunosuppressive agents: cyclosporin, FK-506.
10	Ongoing therapy with drugs known to induce P4503A4 drug metabolism including: phenobarbital, phenytoin, carbamazepine, griseofuvin, and rifampin.

For further information on, or to sign up for this study, please contact the Clinical Investigation Support Office at (323) 865-0451 or the Principal Investigator noted above.