Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Completed

Phase 2

Conditions

Lymphoma

Small Intestine Cancer

Treatments

Drug: CHOP regimen

Drug: doxorubicin hydrochloride

Drug: vincristine sulfate

Drug: cyclophosphamide

Drug: gemcitabine hydrochloride

Drug: prednisone

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00079261

EORTC-20021

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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