Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas - Full Text View

Sponsored by:	Norris Comprehensive Cancer Center
Information provided by:	Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00184002

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Prednisone Vincristine sulfate Vincristine Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Norris Comprehensive Cancer Center:

Estimated Enrollment:	50
Study Start Date:	January 2003
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184002

Locations

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033

Sponsors and Collaborators

Norris Comprehensive Cancer Center

Investigators

Principal Investigator:

Alexandra M. Levine, MD

University of Southern California

More Information

Study ID Numbers:	13NHL-02-3
Study First Received:	September 12, 2005
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00184002
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prednisone
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Lymphoma, small cleaved-cell, diffuse
Vincristine

Cyclophosphamide
Lymphoproliferative Disorders
Aggression
Lymphoma, Non-Hodgkin
Lymphoma
Doxorubicin

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Antibiotics, Antineoplastic

Hormones
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009