Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00969462|
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : July 1, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: Doxorubicin||Phase 4|
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.
Demographic and clinical parameters be collected (Appendix 1)
- 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):
- Episodes of bone marrow depression (leucopenia, neutropenia) Treatment delays Dose reductions Neutropenic fever
- 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
Number of patients: 30
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Association Between Response to Aggressive Chemotherapy and Doxorubicin Pharmacokinetics in Non Hodgkin's Lymphoma Patients|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
No Intervention: Doxorubicin
measurements of serum Doxorubicin levels
- Doxorubicin, pharmacokinetics at first chemotherapy course [ Time Frame: 1 year ]
- Association between doxorubicin pharmacokinetics and response [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969462
|Departmetn of Medicine. Meir Medical Center|
|Kfar-Saba, Israel, 44281|
|Principal Investigator:||Avishay Elis, MD||Meir Medical Center|