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Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00969462
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : July 1, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Doxorubicin Phase 4

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
No Intervention: Doxorubicin
Single arm
Drug: Doxorubicin
measurements of serum Doxorubicin levels




Primary Outcome Measures :
  1. Doxorubicin, pharmacokinetics at first chemotherapy course [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Association between doxorubicin pharmacokinetics and response [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Israel
Departmetn of Medicine. Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Avishay Elis, MD Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00969462     History of Changes
Other Study ID Numbers: 1. NHL
non
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: March 2012

Keywords provided by Meir Medical Center:
Doxorubicin
pharmacokinetics
non-Hodgkin's lymphoma
response
association between response to chemotherapy
myelosuppression degree
doxorubicin pharmacokinetics

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action