Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy SUN 1120
- Conditions
- -C61 Malignant neoplasm of prostateMalignant neoplasm of prostateC61
- Registration Number
- PER-113-08
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 0
• Histological or cytologically confirmed prostate adenocarcinoma.
• Metastatic hormone-refractory prostate cancer (refractory to androgenic ablation). Patients should have ongoing surgical or chemical castration, with a baseline testosterone level <50 ng / dL.
• Patients must have a disease that has not responded to a previous chemotherapy regimen based on docetaxel for the treatment of metastatic disease, defined as the progression of the disease during or after treatment (docetaxel-resistant) or be considered intolerant to docetaxel (The treatment was discontinued due to an unacceptable toxicity, at the discretion of the treating physician or the patient). In the event that both disease progression and drug intolerance are observed during prior treatment with docetaxel, disease progression will be considered the dominant admission criterion.
• Patients must have documented evidence of progressive disease, defined by: The progression of PSA: a minimum of 2 increasing values (in 3 measurements), obtained with a minimum interval of 1 week, the last result being at least 2.0 ng / mL, New or increased non-bone disease RECIST o Positive bone gammagraphy with 2 or more new lesions (PCWG2)
• ECOG performance status of 0 or 1
• Remission of all acute toxic effects of treatment (except alopecia and neuropathy) or prior surgical procedure up to a grade <1 or at the baseline level prior to treatment.
• Appropriate organic function, defined by the following criteria: Serum aspartate transaminase (AST, serum glutamic oxalacetic transaminase [SGOT]) and serum alanine transaminase (ALT, pyruvic glutamic transaminase [SGPT]) <2.5 times the upper limit of normal (ULN), <5 times the ULN in patients with liver metastases. Total serum bilirubin <1.5 times the ULN, Neutrophil absolute count (ANC)> 1500 / pL, Platelets> 100,000 / pL, Hemoglobin> 9.0 g / dL, Serum creatinine <2 times the ULN, QTc interval <470 msec, Fraction of left ventricular ejection (LVEF)> lower limit of normal institutional value (LLN), as observed in a cardiac gammagram (MUGA) or echocardiogram.
• Informed consent document, signed and dated, indicating that the patient (or his legal representative) has been informed of all relevant aspects of the study before enrollment.
• Desire and ability to meet scheduled visits, treatment plans, laboratory tests and other study procedures, including filling out questionnaires about the results reported by the patient and a diary about the use of pain relievers.
• Previous treatment with sunitinib (in any clinical context) and / or more than one previous chemotherapy regimen in the context of metastatic disease treatment.
• Chemotherapy in the 3 weeks prior to the date of the first dose.
• Radioisotope therapy with strontium-89 or sama in the 12 weeks prior to the date of the first dose.
• Radiation therapy (including palliative radiotherapy for metastatic lesions) in the previous 2 weeks or major surgery (eg, open abdominal, pelvic, thoracic, orthopedic or neurosurgery surgery) in the 4 weeks prior to the date of the first dose
• Current treatment in another therapeutic clinical study
• Imminent complication due to bone metastasis (fracture and / or spinal compression). Stable fracture and / or spinal compression Properly treated or stabilized is allowed.
• Presence of ongoing urinary obstruction (eg, urinary retention, hydronephrosis) that requires medical intervention. Properly treated urinary obstruction is allowed.
• Hemorrhage of grade> 3 in the 4 weeks prior to the date of the first dose 9. Cardiac dysrhythmias in progress of grade> 2.
• Hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical treatment).
• Ongoing treatment with therapeutic doses (with therapeutic levels of INR) of coumarin derivatives or oral anti-vitamin K agents.
• Diagnosis of a second cancer in the last 3 years, except for basal cell carcinoma, squamous cell skin cancer, fully treated stage I carcinoma or carcinoma in situ that has been adequately treated, with no evidence of recurrent disease for 12 months .
• Any of the following manifestations in the 6 months prior to the administration of the study drug: severe / unstable angina, myocardial infarction, symptomatic congestive heart failure, pulmonary embolism, stroke or transient ischemic attack.
• History of known brain metastases (cranial metastases allowed), spinal cord compression, carcinomatous meningitis or leptomeningeal disease.
• Infection known by the human immunodeficiency virus (HIV).
• Another severe acute or chronic medical or psychiatric condition or laboratory alteration that could impact, at the discretion of the investigator, on the risk associated with participation in the study or administration of the study drug or that, in the opinion of the investigator, could cause that the patient is inappropriate to enter the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method