Two arm, triple blinded, randomized placebo controlled, prospective, parallel design Phase II integrated phase IIIstudy to evaluate the role of Carica papaya leaf extract (CPLE) in reducing the duration of chemotherapy induced thrombocytopenia and adverse events related to thrombocytopenia. - CPLE PACT

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•Patients with metastatic solid tumor malignancies receiving chemotherapy with the following preconditions
•Platelet counts and clinical parameters as follows
•-No active bleeding from any site or previous history of CIT and related bleeding
•-ECOG PS 0-2
•-Platelet counts in the range - 75,000 and 25,000
•-Hemoglobin levels more than or equal to 8
•-Total leucocyte counts more than or equal to 2000 WBC per microliter and Absolute neutrophil counts more than or equal to 1000 neutrophils per microliter
•-No clinical or radiological evidence of infection/sepsis
•-Not having received growth factors in the last three weeks or not being planned for G-CSF/peg GCSF; not planned for blood or blood product transfusions
•- Received at least 2 prior cycles of the current chemotherapeutic regimen, i.e. only patients from cycle 3 of their current regimen will be considered for inclusion in trial
•-Patients who can give informed consent for the study.
•-Adequate organ function
•Liver functions- bilirubin less than or equal to 2 x upper limit normal (ULN), AST ALT ALP <= 2.5 x ULN, S. albumin more than or equal to 30 g/L
•Adequate Renal function
•-Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial

•Serious co-morbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections.
•-Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia.
•-Patients on other investigational drugs within the last 30 days.
•- Patients with inability to swallow oral medications
•-The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may impair swallowing or capability of oral intake of tablets
•- Platelet counts less than or equal to25,000
•-Patients with documented Grade 2 or grade 3 thrombocytopenia on chemotherapy, but having concurrent newly diagnosed vitamin B12 or folate deficiency that requires supplementation
•-Patients with documented Grade 2 or grade 3 thrombocytopenia on chemotherapy, but having concurrent newly diagnosed iron deficiency anemia satisfying all the following criteria
•-Hemoglobin less than or equal to 10
•-Se ferritin less than 21.8 ng/ml (males) and less than 4.6 ng/ml (females)
•-Transferrin saturation less than 15%
•If not satisfying the above criteria, patients can still be considered for study.
•- Presence of bleeding diathesis
•-Patients receiving Amiodarone currently

发起方