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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00184002
First Posted: September 16, 2005
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Southern California
September 12, 2005
September 16, 2005
July 13, 2017
August 10, 2017
August 10, 2017
January 10, 2003
December 19, 2012   (Final data collection date for primary outcome measure)
Percentage of Patients With Complete Response to the Combination Chemotherapy [ Time Frame: At completion of cycle 4, 6, and 8 ]

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. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study.

Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas" by Cheson et al (23).

Not Provided
Complete list of historical versions of study NCT00184002 on ClinicalTrials.gov Archive Site
Number of Patients With Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: At end of every cycle ]
Summary of grade 3 or higher toxicities (per Common Toxicity Criteria version 2.0) which generally is described as severe adverse reaction or symptom.
Not Provided
Not Provided
Not Provided
 
Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
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.
Experimental: DR-COP

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.
Intervention: Drug: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 7, 2013
December 19, 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00184002
13NHL-02-3
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
University of Southern California
University of Southern California
Ortho Biotech, Inc.
Principal Investigator: Anil Tulpule, MD University of Southern California
University of Southern California
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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