Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
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.
|Lymphoma Small Intestine Cancer||Drug: CHOP regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: gemcitabine hydrochloride Drug: prednisone Drug: vincristine sulfate||Phase 2|
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma|
- Complete response as assessed by Cheson criteria
- Toxicity as assessed by CTC 2.0
- Proportion of courses given as scheduled
- Freedom from treatment failure as assessed by Cheson criteria
|Study Start Date:||January 2004|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079261
|Leuven, Belgium, B-3000|
|Algemeen Ziekenhuis Sint-Augustinus|
|Wilrijk, Belgium, 2610|
|University Hospital Rebro|
|Zagreb, Croatia, 41000|
|National Cancer Institute - Cairo|
|Bordeaux, France, 33076|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Study Chair:||Igor Aurer, MD, PhD||University Hospital Rebro|