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
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