Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status

Trial Information

Phase II Dose Study of Doxil in a Dose Dense, 14 Day CDOP/Rituximab Regimen for Patients With Diffuse Large B-Cell NHL > 60 Years or With Compromised Cardiac Status

Diffuse large B-cell lymphoma (DLBCL) is the most frequent type of non-Hodgkin's lymphoma
with more than half of the patients being over the age of 60 years. Elderly patients with
cancer are defined by the American Society of Clinical Oncology as a "special population"
due to their disease characteristics, additional health problems, and need for aggressive
supportive care strategies to reduce morbidity and mortality. The combination of
cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) remains as standard
therapy for the treatment of DLBCL, but elderly patients tend to tolerate the CHOP therapy
less when compared to younger patients. Cardiac toxicity, as well as decrease in blood
counts, are the most common side effects in the elderly population. For these reasons, many
doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly
for fear of increased morbidity. DLBCL in the elderly is also somewhat unique in that the
elderly patients appear to have more aggressive disease and poor overall outcome. In order
to maximize the tolerability of treatment and thus potentially enhance overall treatment
success in this population, it is necessary to look at alternative treatments. This clinical
trial is based on currently accepted standard NHL therapy (CHOP-Rituximab) in which Doxil is
substituted for Adriamycin. Growth factor will be used for support of acceptable blood
counts. Chemotherapy regimens that include rituximab are now the gold standard for treatment
of DLBCL. If indeed, delivering full dose chemotherapy without treatment delays leads to
higher remission and cure rates, then this offers a significant proportion of NHL patients
who are elderly a chance for cure rather than providing treatment for comfort measures while
preserving quality of life.