DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma

Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Hodgkin's Lymphoma

Intervention: Doxorubicin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Meir Medical Center

Official(s) and/or principal investigator(s):
Avishay Elis, MD, Principal Investigator, Affiliation: Meir Medical Center

Summary

In previous studies, the investigators found that in patients with Hodgkin's lymphoma (HL) treated with ABVD (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment [complete remission (CR) rate 79% versus 31%, P < 0. 0005, respectively]. Also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction [88% vs. 62. 5%, P=0. 05, for the presence of at least one of them]. One of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. There is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression. In a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. However, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower AUC (area under the curve) and 3 fold lower peaks (p=0. 06). The investigators' lack to approve the previous findings might be explained by the small study group.

Clinical Details

Official title: Association Between Response to Aggressive Chemotherapy and Doxorubicin Pharmacokinetics in Non Hodgkin's Lymphoma Patients

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Doxorubicin, pharmacokinetics at first chemotherapy course

Secondary outcome: Association between doxorubicin pharmacokinetics and response

Detailed description: Aim of the study: To evaluate the association between response to chemotherapy, the degree of myelosuppression and the pharmacokinetics of doxorubicin in non-Hodgkin's lymphoma (NHL) patients. Methods: Study protocol: 1. At diagnosis Demographic and clinical parameters be collected (Appendix 1) 2. At course 2: 1. Doxorubicin will be given by 5-7 minutes infusion before the other medications (Doxorubicin doses will be collected (Appendix 1)) 2. Blood will be sampled in course 2, at: 0 minutes 30 minutes 120 minutes 24 hours Two 2ml EDT tubes will be drawn at each time The tubes will be centrifuged at 3000 RPM for

15 min. Plasma samples will be stored in - 700C

3. At the end of chemotherapy courses the following data will be collected (Appendix 2): 1. Episodes of bone marrow depression (leucopenia, neutropenia) Treatment delays Dose reductions Neutropenic fever 2. Remission status

[Complete remission (CR) - disappearance of clinical signs and symptoms of NHL along with

normal laboratory and radiological findings]. 4. At the end of one year of CR Remission status Number of patients: 30

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥ 18 years

- Biopsy proven intermediate grade NHL

- No previous chemotherapy

- At least 4 courses of R-CHOP at maximal doses are planned

- An informed consent

Exclusion Criteria:

- Do not meet all inclusion criteria

Locations and Contacts

Departmetn of Medicine. Meir Medical Center, Kfar-Saba 44281, Israel
Additional Information

Starting date: September 2009
Last updated: June 27, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017