Clinical trial NCT00184002: Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Ortho Biotech, Inc.
First posted: 2005-09-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Patients With Complete Response to the Combination Chemotherapy
timeFrame: At completion of cycle 4, 6, and 8
Secondary outcomes:
measure: Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability
timeFrame: At end of every cycle
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
Study officials:
affiliation: University of Southern California
name: Anil Tulpule, MD
role: PRINCIPAL_INVESTIGATOR
References: