Prostate Cancer Clinical Trials
|Closed||Metastatic Prostate Cancer||Phase II||NCT01718353|
Primary Objectives: - To explore the benefit of an early switch from docetaxel/prednisone to cabazitaxel/ prednisone in men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who do not achieve ≥30% prostate-specific antigen (PSA) decline from baseline by cycle 4 with the initial docetaxel treatment. - To evaluate the circulating tumor cells (CTCs) with clinical response/resistance to docetaxel or cabazitaxel treatment Secondary Objectives: - To assess efficacy and safety of the two treatment strategies, switch from cabazitaxel/prednisone to docetaxel/prednisone and docetaxel/prednisone to cabazitaxel/prednisone. - To evaluate efficacy in patients receiving initial taxane treatment before the switch and efficacy under the alternate taxane after the switch within each initial treatment group.
- Histologically- or cytologically-confirmed prostate adenocarcinoma with documented distant metastases (M1 disease)
- Progressive disease while receiving hormonal therapy or after surgical castration
- Effective castration (serum testosterone levels ≤50 ng/dL) by orchiectomy and/or luteinizing hormone releasing hormone agonists or antagonist with or without anti-androgens.
- Prior chemotherapy for prostate cancer, except estramustine and adjuvant/neoadjuvant treatment completed >3 years ago. Prior treatment with sipuleucel-T immunotherapy is allowed at the condition patient did not received prior chemotherapy.
- Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of random allocation.
- Prior beta isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
- Adverse events (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03) at the time of random allocation.
- Less than 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
- Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed ≥3 years ago and from which the patient has been disease-free for ≥3 years.
- Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to random allocation.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, stroke or transient ischemic attack.
- Any of the following within 3 months prior to random allocation: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
- Acquired immunodeficiency syndrome (AIDS)-related illnesses or known HIV disease requiring antiretroviral treatment.
- Any severe acute or chronic medical condition which could impair the ability of the patient to participate in to the study or interfere with interpretation of study results, or patient unable to comply with the study procedures.
- Concomitant treatment with biphosphonates or denosumab except if the dose has been stable for 12 weeks prior to enrollment
- Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent prior to enrollment into the study.
- Patients with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period. The definition of "effective method of contraception" will be based on the investigator's judgment.
- History of hypersensitivity to docetaxel or polysorbate 80.
- Inadequate organ and bone marrow function
- Contraindications to the use of corticosteroid treatment
- Symptomatic peripheral neuropathy grade >2 (NCI CTCAE v.4.03).
- Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a two-week wash-out period is necessary for patients who are already on these treatments)
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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