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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Cyclophosphamide; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Prednisone; Vincristine

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