NCT00079261CompletedPhase 2
Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
European Organisation for Research and Treatment of Cancer - EORTC11 sites in 5 countries25 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 25
- Locations
- 11
- Primary Endpoint
- Complete response as assessed by Cheson criteria
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:
- •Diffuse large B large cell lymphoma (including all clinical and morphologic variants)
- •Grade 3 follicular lymphoma
- •Extranodal T/NK cell lymphoma, nasal type
- •Enteropathy-type T cell lymphoma
- •Hepato-splenic T cell lymphoma
- •Peripheral T cell lymphoma, unspecified
- •Angioimmunoblastic lymphoma
- •Anaplastic large cell lymphoma, systemic type
- •Stage II-IV disease
- •At least 1 site of measurable disease (e.g., lymph node or lymph node mass)
- •The following subtypes are not allowed:
- •Mantle cell lymphoma
- •Burkitt's lymphoma
- •Precursor B or T cell lymphoma
- •Primary cutaneous B or T cell lymphoma
- •No CNS involvement by lymphoma
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC > 3,000/mm^3
- •Neutrophil count > 1,000/mm^3
- •Platelet count > 100,000/mm^3
- •Bilirubin < 2.5 times normal (unless due to lymphoma)
- •ALT and AST < 2.5 times normal (unless due to lymphoma)
- •Creatinine < 2.0 mg/dL
- •Cardiovascular
- •No severe cardiac disease that would preclude study participation or limit life expectancy
- •FEV_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)
- •No severe pulmonary disease that would preclude study participation or limit life expectancy
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- •No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent monoclonal antibodies
- •Chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy
- •No concurrent radiotherapy
- +5 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Complete response as assessed by Cheson criteria
Secondary Outcomes
- Toxicity as assessed by CTC 2.0
- Proportion of courses given as scheduled
- Freedom from treatment failure as assessed by Cheson criteria
Investigators
Study Sites (11)
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