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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the percentage of patients with complete response to the combination chemotherapy

Outcome Description:

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.

Outcome Time Frame:

At completion of cycle 4

Safety Issue:

No

Principal Investigator

Alexandra M. Levine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Food and Drug Administration

Study ID:

13NHL-02-3

NCT ID:

NCT00184002

Start Date:

January 2003

Completion Date:

June 2014

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804