Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma

NCT00969462 | Completed Phase 4

• 2 other identifiers: 1. NHLnon
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Hodgkin's Lymphoma

Keywords

Doxorubicin; pharmacokinetics; non-Hodgkin's lymphoma; response; association between response to chemotherapy; myelosuppression degree; doxorubicin pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Doxorubicin, pharmacokinetics at first chemotherapy course

  1 year

Secondary Outcomes (1)

• Association between doxorubicin pharmacokinetics and response

  1 year

Study Arms (1)

Doxorubicin

NO INTERVENTION

Single arm

Drug: Doxorubicin

Interventions

Doxorubicin DRUG

measurements of serum Doxorubicin levels

Doxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Departmetn of Medicine. Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Avishay Elis, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: September 1, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: July 1, 2013

Record last verified: 2012-03

Locations

IL (1)