Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
18 Years
70 Years
Both
Lymphoma, Small Intestine Cancer
Trial Information
Gem-CHOP: A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkin's Lymphoma
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.
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:
Age
- 18 to 70
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
Hepatic
- Bilirubin < 2.5 times normal (unless due to lymphoma)
- ALT and AST < 2.5 times normal (unless due to lymphoma)
Renal
- Creatinine < 2.0 mg/dL
Cardiovascular
- No severe cardiac disease that would preclude study participation or limit life
expectancy
Pulmonary
- FEV_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)
- No severe pulmonary disease that would preclude study participation or limit life
expectancy
Other
- 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
Surgery
- Not specified
Other
- No prior cytotoxic agents
- No prior treatment for NHL
- No other concurrent anticancer therapy
- No other concurrent investigational drugs
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response as assessed by Cheson criteria
Safety Issue:
No
Principal Investigator
Igor Aurer, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Rebro
Authority:
United States: Federal Government
Study ID:
EORTC-20021
NCT ID:
NCT00079261
Start Date:
January 2004
Completion Date:
Related Keywords:
- Lymphoma
- Small Intestine Cancer
- 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
- Lymphoma
- Lymphoma, Non-Hodgkin
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
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