EUCTR2005-002717-21-DE进行中（未招募）不适用
A PHASE 2, RANDOMIZED, NON-COMPARATIVE, TWO-ARM OPEN LABEL, MULTIPLE-CENTER STUDY OF CP-751,871 IN COMBINATION WITH DOCETAXEL/PREDNISONE IN CHEMOTHERAPY- NAÏVE (ARM A) AND DOCETAXEL/PREDNISONE REFRACTORY (ARM B) PATIENTS WITH HORMONE INSENSITIVE PROSTATE CANCER - CP-751,871 in Hormone-Refractory Metastiatic Prostate Cancer
Pfizer Inc. 235 East 42nd Street, New York, NY 10017, USA0 个研究点目标入组 200 人开始时间: 2007年11月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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 of prior cancer therapy. CTCAEs > 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
- •11.Adequate blood chemistry parameters as defined by:
- •- Creatinine <1.7 mg/dL (equivalent to 151 micromol/L). If creatinine is
- •>1.7 mg/dL, the calculated creatinine clearance must be >40 ml/min
- •from the Cockcroft Gault or MDRD formulas (Appendix D).
- •- Bilirubin - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
- •<1.5 x ULN
- •12. Hemoglobin >10 g/dL.
- •13. Written and voluntary informed consent understood, signed and
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 59
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
排除标准
- •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
- •XML File Identifier: ymSjofh/N0gbQ+W7XKzIzaJJGjI=
- •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.
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