Text Size

Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma

This study is currently recruiting participants.
Verified March 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00969462
First received: August 17, 2009
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
 Drug: Doxorubicin
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Association Between Response to Aggressive Chemotherapy and Doxorubicin Pharmacokinetics in Non Hodgkin's Lymphoma Patients

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Doxorubicin, pharmacokinetics at first chemotherapy course [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association between doxorubicin pharmacokinetics and response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Doxorubicin
    measurements of serum Doxorubicin levels
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969462

Contacts
Contact: Avishay Elis, MD 09-7472185 avishayel@clalit.org.il

Locations
Israel
Departmetn of Medicine. Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Contact: Avishay Elis, MD     09-7472185     avishayel@clalit.org.il    
Principal Investigator: Avishay Elis, MD            
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Avishay Elis, MD Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00969462     History of Changes
Other Study ID Numbers: 1. NHL, non
Study First Received: August 17, 2009
Last Updated: March 15, 2012
Health Authority: Israel: non

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
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013