Metastatic hormone refractory (androgen indepedent) progressive prostate cancer (HRPC) MedDRA version: 13.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: CP-751,871
Pharmaceutical Form: Solution for infusion
Current Sponsor code: CP-751,871
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Pfizer Inc,235 East 42nd Street, New York,NY 10017
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed adenocarcinoma of the prostate (a new diagnostic biopsy is not required). 2.Evidence of metastatic disease either on bone or CT scans. 3.At least 18 years old. 4.PSA above 5 ng/mL. 5.Progressive disease after at least 1 hormonal treatment (orchiectomy, estrogens, LHRH therapy etc.) with documented testosterone levels less than 50 ng/dL (equivalent to 1.7 nmol/L) and progressive disease defined by the following: - An increase in PSA>50% over nadir value on hormonal therapy measured on 3 successive occasions at least 1 week a part. If the third measurement is lower than the second, a fourth measurement will be taken. Only if the fourth measurement is higher than the second, the patient will be enrolled in the study. - Disease progression as defined by RECIST - Two or more new bone lesions 6.Concurrent use of LHRH agonist is required if the patient has not been surgically castrated. 7.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 determined within 2 weeks prior to enrollment (Appendix E). 8.Recovered to CTCAE Grade 1 that are not considered a safety risk by the sponsor and investigator will be allowed. 9.Stable level of pain for at least one week before enrollment. 10.Absolute neutrophil count of >1.5 x 109/L and platelets >100 x 109/L. 11.Adequate blood chemistry parameters as defined by: - Creatinine 1.7 mg/dL, the calculated creatinine clearance must be >40 ml/min from the Cockcroft Gault or MDRD formulas (Appendix D). - Bilirubin 10 g/dL. 13. Written and voluntary informed consent understood, signed and dated. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Prior chemotherapy or radioisotopes treatment for prostate cancer. 2.Prior anti IGF 1R and antibody based investigational therapies. Other investigational therapies (targeted or vaccine), unless otherwise agreed by investigators and sponsor, will require 4 weeks wash out period before enrollment. 3.Antiandrogen therapy (eg, flutamide) for primary cancer within 4 weeks prior to enrollment (6 weeks in the case of bicalutamide, nilutamide or other long acting anti androgens). 4.Radiation therapy to more than 25% of the bone marrow. 5.Local radiation within 2 weeks of enrollment. 6.Surgery within 4 weeks prior to study enrollment or not fully recovered from side effects of previous procedures. 7.Use of products known to affect PSA levels within 4 weeks of enrollment (eg, PC Calm, PC Plus, PC SPES, finasteride). 8.A serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment. 9.Significant active cardiac disease including: uncontrolled high blood pressure (ie, systolic blood pressure >160 mmHg, diastolic blood pressure >95 mm Hg), unstable angina, deep venous thrombosis, pulmonary embolism, cerebro vascular attack, valvular disease, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias. 10.Subjects who are receiving chronic high dose immunosuppressive steroid therapy. Use of high dose corticosteroids within 2 weeks prior to enrollment (=100 mg prednisone per day or >40 mg dexamethasone per day). Previous steroid treatment is allowed but must be stopped at enrollment. Low dose steroid use for the control of nausea and vomiting (eg, dexamethasone 20 mg/day for up to 5 days) will be allowed. Topical steroid use is permitted. Inhaled steroids are permitted. Use of dexamethasone as pre medication is not an exclusion criterion. 11. Known severe hypersensitivity reactions to docetaxel or other drugs formulated in polysorbate 80. 12. Medical contraindication to any of the docetaxel pre medications. 13. Neuropathy greater than Grade 1 or evidence of unstable neurological symptoms within 4 weeks prior to enrollment. 14. Brain metastasis. Unevaluated central nervous system (CNS) symptoms suggestive of brain metastases within 2 weeks prior to enrollment. CNS symptoms must be evaluated with a computerized tomography (CT) scan or magnetic resonance imaging (MRI). 15. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 16. Subjects with reproductive potential who are not using adequate barrier methods on treatment. 17. Active malignancy other than prostate cancer within the past five years with the exception of non melanoma skin cancer (basal or squamous-cell skin cancer). 18. Subjects who have been admitted to an institution by virtue of an order issued by either the judicial or administrative authorities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study procedures to be followed after March 31, 2011 are outlined in Appendix M of the protocol. Primary Objective: • Arm A: To assess the efficacy, in term of PSA response rate, of multiple doses of CP 751,871 in combination with docetaxel and prednisone in chemotherapy-naïve patients with HRPC. • Arm B: To assess the efficacy, in terms of PSA response rate, of CP-751,871 in combination with docetaxel/prednisone in patients with HRPC that progress on docetaxel/prednisone alone. ; Secondary Objective: • To assess efficacy in terms of PFS (progression free survival). • To assess the safety and tolerability of multiple doses of CP-751,871 in combination with docetaxel and prednisone. • To assess population PK of CP-751,871 when used in combination with docetaxel and prednisone. • To evaluate the effect of CP-751,871 in combination with docetaxel and prednisone on biomarkers. • To test for the occurrence of HAHA response to CP-751,871. • The feasibility of performing quality of life and pain questionnaires in this patient population will be investigated. ;Primary end point(s): PSA Response Rate | — |
Countries
Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed