Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
Condition: Lymphoma; Small Intestine Cancer
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Intestinal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,
      prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so
      they stop growing or die. Combining more than one chemotherapy drug may kill more cancer
      cells.

      PURPOSE: This randomized phase II trial is studying giving combination chemotherapy together
      with gemcitabine to see how well it works compared to giving combination chemotherapy alone
      in treating patients with previously untreated aggressive stage II, stage III, or stage IV
      non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the complete response rate (confirmed or unconfirmed) in patients with
           previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide,
           doxorubicin, vincristine, and prednisone with vs without gemcitabine.

      Secondary

        -  Compare the safety profile of these regimens in these patients.

        -  Compare the feasibility of these regimens, defined as the proportion of courses given as
           scheduled, in these patients.

        -  Compare freedom from treatment failure in patients treated with these regimens.

      OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified
      according to participating center, International Prognostic Index score (0-2 vs 3-5), and
      histology (B cell vs T cell). Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive CHOP chemotherapy comprising cyclophosphamide IV, doxorubicin
           IV, and vincristine IV on day 1 and oral or IV prednisone on days 1-5.

        -  Arm II: Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30
           minutes on days 1 and 8.

      In both arms, treatment repeats every 3 weeks for 3 courses in the absence of unacceptable
      toxicity or progressive disease. Patients achieving partial response or complete or
      unconfirmed complete response receive an additional 5 courses of therapy (for a total of 8
      courses).

      Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 76-82 patients (38-41 per treatment arm) will be accrued for
      this study within 2 years.
    

Intervention name(s): CHOP regimen; cyclophosphamide; doxorubicin hydrochloride; gemcitabine hydrochloride; prednisone; vincristine sulfate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Cyclophosphamide; Gemcitabine; Doxorubicin; Liposomal doxorubicin; Vincristine
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contiguous stage II grade 3 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; stage III grade 3 follicular lymphoma; stage IV grade 3 follicular lymphoma; contiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; adult grade III lymphomatoid granulomatosis; small intestine lymphoma