neuroendocrine prostate cancer
Conditions
Interventions
1:Carbidopa 25 mg/d
2:Carbidopa 75 mg/d
3:Carbidopa 125 mg/d
4:Carbidopa 175 mg/d
Sponsors
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male, aged >= 18 years; 2. Prostate cancer meets at least one of the following criteria: (1) Histological diagnosis of small cell or neuroendocrine prostate cancer; (2) Histological diagnosis of prostate cancer plus immunohistochemical staining for neuroendocrine markers (CHGA, SYP, CD56, or NSE) > 50%; 3. After 4 cycles of platinum-based chemotherapy, disease status was evaluated every 2 cycles during the period, all of which were progressive or did not respond to platinum-based therapy. The evaluation criteria were as follows: (1) Progress: the serum PSA level was detected every 1 week, and the PSA level continued to increase for 3 consecutive times, which was more than 50% higher than the basic value; (2) Imaging progress: CT or MRI or PET/CT examination found that the original tumor lesion was enlarged compared with the previous examination, and the new tumor metastasis or the original tumor metastasis was found to be enlarged; 4. The ECOG score is 0-2; 5. Platelet count >= 75 x 10^9/L, PT duration = 3.5 x 10^9/L, neutrophils >= 1.7 x 10^9/L; 7. Liver function: ALT <= 2.5 x ULN, AST <= 2.5 x ULN 8. Renal function: serum creatinine <= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Patients with uncorrected coagulopathy and obvious bleeding tendency; 2. Patients who need long-term anticoagulation and antiplatelet therapy and cannot be stopped; 3. Patients with unstable or active ulcers or gastrointestinal bleeding; 4. Patients with current heart disease which requires treatment or with hypertensive emergencies; 5. Patients with interstitial pneumonia; 6. Patients with a definite active infection; 7. Chemoradiotherapy for the study disease or other chemotherapy for the tumor was administered within 4 weeks before the start of the study; 8. Patients who are allergic to carbidopa or related preparations; 9. Patients with contraindications for the use of carbidopa and levodopa, such as severe cardiovascular diseases, hepatic and renal dysfunction, endocrine disorders, mental disorders, severe arrhythmias, heart failure, glaucoma, convulsions history, etc.; 10. Patients who receiving other concomitant antitumor therapy; 11. The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the maximum tolerated dose (MTD) of compound carbidopa tablets;recommended phase II dose of compound carbidopa tablets; | — |
Secondary
| Measure | Time frame |
|---|---|
| assessment criteria of target lesion or non-target lesion in the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines;progression-free survival (PFS): the interval between initiation of therapy and tumor progression (or death);overall survival (OS): the interval between initiation of treatment and death; | — |
Countries
China
Contacts
Public ContactZhu Yinjie
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed