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

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

Overview[ - collapse ][ - ]

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	Non-Hodgkin's Lymphoma
Intervention	Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone
Phase	Phase 2
Sponsor	University of Southern California
Responsible Party	University of Southern California
ClinicalTrials.gov Identifier	NCT00184002
First Received	September 12, 2005
Last Updated	November 27, 2013
Last verified	November 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 12, 2005
Last Updated Date	November 27, 2013
Start Date	January 2003
Estimated Primary Completion Date	June 2015
Current Primary Outcome Measures	To determine the percentage of patients with complete response to the combination chemotherapy [Time Frame: At completion of cycle 4] [Designated as safety issue: No]Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response.
Current Secondary Outcome Measures	Number of patients with Adverse Events as a Measure of Safety and Tolerability [Time Frame: At end of every cycle] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Non-Hodgkin's Lymphoma
Intervention	Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) Prednisone 100 mg po days 1-5 1 cycle = 21 days. Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Study Arm (s)	Experimental: Arm I On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 1 cycle = 21 days. Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	68
Estimated Completion Date	June 2015
Estimated Primary Completion Date	June 2014
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00184002
Other Study ID Numbers	13NHL-02-3
Has Data Monitoring Committee	Not Provided
Information Provided By	University of Southern California
Study Sponsor	University of Southern California
Collaborators	Ortho Biotech, Inc.
Investigators	Principal Investigator: Anil Tulpule, MD University of Southern California
Verification Date	November 2013

Locations[ + expand ][ + ]