A Phase 1b Dose Escalation Trial of PSK®/Placebo With Docetaxel to Treat Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT01685489
Last Updated: 2015-10-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE1
Study Classification
INTERVENTIONAL
Study Start Date
2013-05-31
Brief Summary
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This is a phase 1b study that follows a 3+3 dose escalation design and consists of a 21-day lead-in period of oral Polysaccharide Krestin (PSK)/placebo (study drug) alone followed by the addition to study drug of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. Study drug will be discontinued on day 15 of the third docetaxel cycle to allow for a 7-day washout period before the fourth dose of docetaxel. Pharmacokinetic (PK) analysis of docetaxel will be conducted during docetaxel cycle 1 (combination therapy) and cycle 4 (docetaxel alone). Serum for future PSK PK analysis will be collected on days 1, 3, and 15 of PSK/placebo lead-in and during cycles 1 and 4.
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Detailed Description
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Conditions
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Prostatic Neoplasms
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Docetaxel, PSK®
A 21-day lead-in oral PSK alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 evey 3 weeks for three cycles. After the third dose of docetaxel, study drug will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered.
Group Type
EXPERIMENTAL
Docetaxel, PSK®
Intervention Type
DRUG
Docetaxel, Placebo
A 21-day lead-in oral placebo alone is followed by the addition of standard intravenous docetaxel at 75 mg/m2 every 3 weeks for three cycles. After the third dose of docetaxel, the placebo will be discontinued on day 14 to allow for a 7-day washout period before a fourth dose of docetaxel is administered.
Group Type
PLACEBO_COMPARATOR
Docetaxel, Placebo
Intervention Type
DRUG
Interventions
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Docetaxel, PSK®
Intervention Type
DRUG
Docetaxel, Placebo
Intervention Type
DRUG
Other Intervention Names
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Polysaccharide-K
Krestin
Polysaccharide-Kureha
Eligibility Criteria
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Inclusion Criteria
* Male patients 18 years or older
* Histologically confirmed diagnosis of adenocarcinoma of the prostate
* Evidence of metastatic disease by standard imaging studies (bone scan, Computerized Tomography Scan (CT) or Magnetic Resonance Imaging (MRI))
* Testosterone levels \<50 ng/dL
* Confirmed progressive disease defined by one or more of the following:
* an increase in PSA, \> 2ng/dL x 2 or more values at least 1 week apart in the setting of metastatic disease
* appearance of new bone lesions on bone scan
* progression of soft tissue lesion defined by the Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1 criteria
* Concurrent use of an agent for testosterone suppression (e.g., Luteinizing Hormone Releasing Hormone \[LHRH\] agonist) if the patient is not surgically castrate
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 determined within 28 days before enrollment
* Recovery to CTCAE grade ≤ 1 toxicity, to patient's baseline status (except alopecia), or toxicities deemed irreversible from the effects of prior cancer therapy (CTCAEs grade \> 1 that are not considered a safety risk by the investigator will be allowed)
* Adequate bone marrow function defined as:
* absolute neutrophil count (ANC) \> 1500 cells/mm³ without growth factor support
* platelet count \> 100,000 cells/mm³ without transfusion or growth factor support
* hemoglobin \> 9g/dL without transfusion or growth factor support
* Adequate liver function defined as:
* total bilirubin \< upper limit of normal (ULN)
* alanine aminotransferase (ALT) \< 1.5 x ULN
* aspartate aminotransferase (AST) \< 1.5 x ULN
* Adequate renal function defined as serum creatinine level within normal limits (WNL)
* At least a 6-month or greater life expectancy
* Ability to understand and sign a written informed consent, which will be obtained from study participants before undergoing any study-specific procedures
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
* Suitable venous access for the study-required blood sampling (i.e., including PK sampling)
* Histologically confirmed diagnosis of adenocarcinoma of the prostate
* Evidence of metastatic disease by standard imaging studies (bone scan, Computerized Tomography Scan (CT) or Magnetic Resonance Imaging (MRI))
* Testosterone levels \<50 ng/dL
* Confirmed progressive disease defined by one or more of the following:
* an increase in PSA, \> 2ng/dL x 2 or more values at least 1 week apart in the setting of metastatic disease
* appearance of new bone lesions on bone scan
* progression of soft tissue lesion defined by the Response Evaluation Criteria In Solid Tumors \[RECIST\] 1.1 criteria
* Concurrent use of an agent for testosterone suppression (e.g., Luteinizing Hormone Releasing Hormone \[LHRH\] agonist) if the patient is not surgically castrate
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 determined within 28 days before enrollment
* Recovery to CTCAE grade ≤ 1 toxicity, to patient's baseline status (except alopecia), or toxicities deemed irreversible from the effects of prior cancer therapy (CTCAEs grade \> 1 that are not considered a safety risk by the investigator will be allowed)
* Adequate bone marrow function defined as:
* absolute neutrophil count (ANC) \> 1500 cells/mm³ without growth factor support
* platelet count \> 100,000 cells/mm³ without transfusion or growth factor support
* hemoglobin \> 9g/dL without transfusion or growth factor support
* Adequate liver function defined as:
* total bilirubin \< upper limit of normal (ULN)
* alanine aminotransferase (ALT) \< 1.5 x ULN
* aspartate aminotransferase (AST) \< 1.5 x ULN
* Adequate renal function defined as serum creatinine level within normal limits (WNL)
* At least a 6-month or greater life expectancy
* Ability to understand and sign a written informed consent, which will be obtained from study participants before undergoing any study-specific procedures
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
* Suitable venous access for the study-required blood sampling (i.e., including PK sampling)
Exclusion Criteria
* Prior treatment with antineoplastic chemotherapy or radioisotopes for metastatic disease
* Prior adjuvant or neo-adjuvant chemotherapy within 12 months of study entry
* Last dose of sipuleucel-T therapy within 4 weeks of enrollment
* Any investigational therapies within 4 weeks of study entry
* Radiotherapy within 4 weeks of study entry
* Major surgery within 4 weeks of study entry, and not fully recovered to baseline or a stable clinical status
* Uncontrolled high blood pressure (systolic blood pressure \> 160mmHg, diastolic blood pressure \> 95mmHg)
* Receiving chronic steroid therapy. Topical and inhaled steroids are permitted
* Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80, or to mushroom products
* Any comorbid condition or unresolved toxicity that would preclude administration of docetaxel
* Medical contraindication to any docetaxel pre-medications
* History of \> grade 2 neurotoxicity or any toxicity from any cause that has not resolved to \< grade 1
* Brain or other CNS metastasis
* The need for chronic daily immunosuppressive therapy, including concurrent use of prednisone
* Evidence of active second malignancy, except non-melanoma skin cancer
* Infection requiring intravenous antibiotic therapy or other severe infection within 14 days preceding first dose of study drug
* Inability to swallow oral medication or maintain a fast, as required 2 hours before and 1 hour after PSK administration
* Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction
* Other medical or psychiatric condition that may increase the risk associated with trial participation or any other condition in the judgment of the investigator that may interfere with the interpretation of trial results or would make the patient inappropriate for enrollment in this trial
* Prior adjuvant or neo-adjuvant chemotherapy within 12 months of study entry
* Last dose of sipuleucel-T therapy within 4 weeks of enrollment
* Any investigational therapies within 4 weeks of study entry
* Radiotherapy within 4 weeks of study entry
* Major surgery within 4 weeks of study entry, and not fully recovered to baseline or a stable clinical status
* Uncontrolled high blood pressure (systolic blood pressure \> 160mmHg, diastolic blood pressure \> 95mmHg)
* Receiving chronic steroid therapy. Topical and inhaled steroids are permitted
* Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80, or to mushroom products
* Any comorbid condition or unresolved toxicity that would preclude administration of docetaxel
* Medical contraindication to any docetaxel pre-medications
* History of \> grade 2 neurotoxicity or any toxicity from any cause that has not resolved to \< grade 1
* Brain or other CNS metastasis
* The need for chronic daily immunosuppressive therapy, including concurrent use of prednisone
* Evidence of active second malignancy, except non-melanoma skin cancer
* Infection requiring intravenous antibiotic therapy or other severe infection within 14 days preceding first dose of study drug
* Inability to swallow oral medication or maintain a fast, as required 2 hours before and 1 hour after PSK administration
* Uncontrolled pain at baseline, impending complication from bone metastasis and/or presence of urinary obstruction
* Other medical or psychiatric condition that may increase the risk associated with trial participation or any other condition in the judgment of the investigator that may interfere with the interpretation of trial results or would make the patient inappropriate for enrollment in this trial
Minimum Eligible Age
18 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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University of Washington
OTHER
Sponsor Role
collaborator
Fred Hutchinson Cancer Center
OTHER
Sponsor Role
collaborator
Bastyr University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Celestia Higano, MD
Role: STUDY_DIRECTOR
Seattle Cancer Care Alliance - University of Washington
Cynthia A Wenner, Ph.D
Role: STUDY_DIRECTOR
Bastyr University
Leanna J Standish, PhD, ND, LAc
Role: PRINCIPAL_INVESTIGATOR
Bastyr University
Mary (Nora) L Disis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Seattle Cancer Care Alliance
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Antonarakis ES, Drake CG. Current status of immunological therapies for prostate cancer. Curr Opin Urol. 2010 May;20(3):241-6. doi: 10.1097/MOU.0b013e3283381793.
Reference Type
BACKGROUND
de Bono JS, Scher HI, Montgomery RB, Parker C, Miller MC, Tissing H, Doyle GV, Terstappen LW, Pienta KJ, Raghavan D. Circulating tumor cells predict survival benefit from treatment in metastatic castration-resistant prostate cancer. Clin Cancer Res. 2008 Oct 1;14(19):6302-9. doi: 10.1158/1078-0432.CCR-08-0872.
Reference Type
BACKGROUND
Fisher M, Yang LX. Anticancer effects and mechanisms of polysaccharide-K (PSK): implications of cancer immunotherapy. Anticancer Res. 2002 May-Jun;22(3):1737-54.
Reference Type
BACKGROUND
Fizazi K, Sternberg CN, Fitzpatrick JM, Watson RW, Tabesh M. Role of targeted therapy in the treatment of advanced prostate cancer. BJU Int. 2010 Mar;105(6):748-67. doi: 10.1111/j.1464-410X.2010.09236.x.
Reference Type
BACKGROUND
Fujita H, Ogawa K, Ikuzawa M, Muto S, Matsuki M, Nakajima S, Shimamura M, Togawa M, Yoshikumi C, Kawai Y. Effect of PSK, a protein-bound polysaccharide from Coriolus versicolor, on drug-metabolizing enzymes in sarcoma-180 bearing and normal mice. Int J Immunopharmacol. 1988;10(4):445-50. doi: 10.1016/0192-0561(88)90132-4.
Reference Type
BACKGROUND
Hurria A, Fleming MT, Baker SD, Kelly WK, Cutchall K, Panageas K, Caravelli J, Yeung H, Kris MG, Gomez J, Miller VA, D'Andrea G, Scher HI, Norton L, Hudis C. Pharmacokinetics and toxicity of weekly docetaxel in older patients. Clin Cancer Res. 2006 Oct 15;12(20 Pt 1):6100-5. doi: 10.1158/1078-0432.CCR-06-0200.
Reference Type
BACKGROUND
Iino Y, Yokoe T, Maemura M, Horiguchi J, Takei H, Ohwada S, Morishita Y. Immunochemotherapies versus chemotherapy as adjuvant treatment after curative resection of operable breast cancer. Anticancer Res. 1995 Nov-Dec;15(6B):2907-11.
Reference Type
BACKGROUND
Ikuzawa M, Matsunaga K, Nishiyama S, Nakajima S, Kobayashi Y, Andoh T, Kobayashi A, Ohhara M, Ohmura Y, Wada T, et al. Fate and distribution of an antitumor protein-bound polysaccharide PSK (Krestin). Int J Immunopharmacol. 1988;10(4):415-23. doi: 10.1016/0192-0561(88)90128-2.
Reference Type
BACKGROUND
Lu H, Yang Y, Gad E, Inatsuka C, Wenner CA, Disis ML, Standish LJ. TLR2 agonist PSK activates human NK cells and enhances the antitumor effect of HER2-targeted monoclonal antibody therapy. Clin Cancer Res. 2011 Nov 1;17(21):6742-53. doi: 10.1158/1078-0432.CCR-11-1142. Epub 2011 Sep 14.
Reference Type
BACKGROUND
Makkouk A, Abdelnoor AM. The potential use of Toll-like receptor (TLR) agonists and antagonists as prophylactic and/or therapeutic agents. Immunopharmacol Immunotoxicol. 2009;31(3):331-8. doi: 10.1080/08923970902802926.
Reference Type
BACKGROUND
Mickey DD, Bencuya PS, Foulkes K. Effects of the immunomodulator PSK on growth of human prostate adenocarcinoma in immunodeficient mice. Int J Immunopharmacol. 1989;11(7):829-38. doi: 10.1016/0192-0561(89)90137-9.
Reference Type
BACKGROUND
Nakazato H, Koike A, Saji S, Ogawa N, Sakamoto J. Efficacy of immunochemotherapy as adjuvant treatment after curative resection of gastric cancer. Study Group of Immunochemotherapy with PSK for Gastric Cancer. Lancet. 1994 May 7;343(8906):1122-6. doi: 10.1016/s0140-6736(94)90233-x.
Reference Type
BACKGROUND
Oba K, Teramukai S, Kobayashi M, Matsui T, Kodera Y, Sakamoto J. Efficacy of adjuvant immunochemotherapy with polysaccharide K for patients with curative resections of gastric cancer. Cancer Immunol Immunother. 2007 Jun;56(6):905-11. doi: 10.1007/s00262-006-0248-1. Epub 2006 Nov 15.
Reference Type
BACKGROUND
Odabasi Z, Mattiuzzi G, Estey E, Kantarjian H, Saeki F, Ridge RJ, Ketchum PA, Finkelman MA, Rex JH, Ostrosky-Zeichner L. Beta-D-glucan as a diagnostic adjunct for invasive fungal infections: validation, cutoff development, and performance in patients with acute myelogenous leukemia and myelodysplastic syndrome. Clin Infect Dis. 2004 Jul 15;39(2):199-205. doi: 10.1086/421944. Epub 2004 Jun 28.
Reference Type
BACKGROUND
Ostrosky-Zeichner L, Alexander BD, Kett DH, Vazquez J, Pappas PG, Saeki F, Ketchum PA, Wingard J, Schiff R, Tamura H, Finkelman MA, Rex JH. Multicenter clinical evaluation of the (1-->3) beta-D-glucan assay as an aid to diagnosis of fungal infections in humans. Clin Infect Dis. 2005 Sep 1;41(5):654-9. doi: 10.1086/432470. Epub 2005 Jul 21.
Reference Type
BACKGROUND
Sakamoto J, Morita S, Oba K, Matsui T, Kobayashi M, Nakazato H, Ohashi Y; Meta-Analysis Group of the Japanese Society for Cancer of the Colon Rectum. Efficacy of adjuvant immunochemotherapy with polysaccharide K for patients with curatively resected colorectal cancer: a meta-analysis of centrally randomized controlled clinical trials. Cancer Immunol Immunother. 2006 Apr;55(4):404-11. doi: 10.1007/s00262-005-0054-1. Epub 2005 Aug 20.
Reference Type
BACKGROUND
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, Oudard S, Theodore C, James ND, Turesson I, Rosenthal MA, Eisenberger MA; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720.
Reference Type
BACKGROUND
van Zuylen L, Verweij J, Nooter K, Brouwer E, Stoter G, Sparreboom A. Role of intestinal P-glycoprotein in the plasma and fecal disposition of docetaxel in humans. Clin Cancer Res. 2000 Jul;6(7):2598-603.
Reference Type
BACKGROUND
Wenner CA, Martzen MR, Lu H, Verneris MR, Wang H, Slaton JW. Polysaccharide-K augments docetaxel-induced tumor suppression and antitumor immune response in an immunocompetent murine model of human prostate cancer. Int J Oncol. 2012 Apr;40(4):905-13. doi: 10.3892/ijo.2011.1292. Epub 2011 Dec 12.
Reference Type
BACKGROUND
Wils P, Phung-Ba V, Warnery A, Lechardeur D, Raeissi S, Hidalgo IJ, Scherman D. Polarized transport of docetaxel and vinblastine mediated by P-glycoprotein in human intestinal epithelial cell monolayers. Biochem Pharmacol. 1994 Oct 7;48(7):1528-30. doi: 10.1016/0006-2952(94)90580-0.
Reference Type
BACKGROUND
Zhou SF. Structure, function and regulation of P-glycoprotein and its clinical relevance in drug disposition. Xenobiotica. 2008 Jul;38(7-8):802-32. doi: 10.1080/00498250701867889.
Reference Type
BACKGROUND
Related Links
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http://www.bastyr.edu
General information of Bastyr University
Other Identifiers
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