Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
Information source: Norris Comprehensive Cancer Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Non-Hodgkin's Lymphoma
Intervention: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Norris Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Alexandra M. Levine, MD, Principal Investigator, Affiliation: University of Southern California
Summary
The current standard treatment for non-Hodgkin's lymphoma involves drugs called
cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called
"R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of
people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been
reformulated and been placed in a fatty bubble called a liposome. The reason for placing the
drug in the liposome is that there is evidence that the liposome is better taken up by
tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or
better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved
for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By
substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be
better at shrinking tumors and with reduced side effects. The purpose of this study is to
see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and
prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.
Clinical Details
Official title: A Phase II Study Of Pegylated Liposomal Doxorubicin (Doxil) In Combination With Rituxan, Cyclophosphamide, Vincristine and Prednisone (DR-COP) In Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pathologic diagnosis of Non-Hodgkin's lymphoma of B-cell origin: follicular large
cell, diffuse large cell (including all B-cell variants), Burkitt or Burkitt-like
lymphoma
- All stages of disease
- Measurable or evaluable tumor parameter(s)
- Age greater than 17 years old
- Karnofsky performance status greater or equal to 50%
- AGC greater or equal to 1. 0; platelets greater or equal to 75,000(unless abnormal
because of lymphoma)
- Bilirubin less or equal to 2. 0; SGOT less or equal to 3 times upper limit of normal
(unless abnormal because of lymphoma)
- Creatinine less or equal to 2. 0 or creatinine clearance greater or equal to 60 ml/min
(unless abnormal because of lymphoma)
- LVEF greater or equal to 45%
- Concurrent RT with or without steroids for emergency conditions secondary to lymphoma
(i. e., CNS tumor, cord compression)are permitted
- Men and women of childbearing potential must agree to use adequate birth control for
the duration of the therapy and for 3 months after completion of therapy
- Signed informed consent
Exclusion Criteria:
- Prior systemic cytotoxic therapy or RT for lymphoma
- Second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer
- HIV seropositive
- Primary CNS lymphoma
- Pregnant or nursing women
- Unable to comply with the requirements of the protocol, or unable to provide adequate
informed consent, in the opinion of the PI
Locations and Contacts
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California 90033, United States
Additional Information
Starting date: January 2003
Ending date: December 2007
Last updated: January 11, 2008
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