Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of combination chemotherapy with or without etoposide in treating older patients who have non-Hodgkin's lymphoma that has not been previously treated.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of diffuse large B-cell* or peripheral T-cell non-Hodgkin's lymphoma by REAL/WHO classification, including the following:

• All morphological and clinical variants

• All Ann Arbor stages NOTE: *Presence of a small cell, indolent lymphoma component in the bone marrow biopsy is allowed

• No Burkitt-like lymphoma

• Previously untreated disease

• No cerebral or meningeal involvement

• At least 1 measurable target lesion at least 1.1 cm by the Cheson criteria

PATIENT CHARACTERISTICS:

Age

• 70 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3 (unless related to bone marrow infiltration)

Hepatic

• Bilirubin less than 1.8 mg/dL*

• AST or ALT less than 2.5 times upper limit of normal (ULN)*

• Alkaline phosphatase less than 4 times ULN* NOTE: *Values above these thresholds are allowed only if related to non-Hodgkin's lymphoma

Renal

• Creatinine clearance at least 50 mL/min

Cardiovascular

• LVEF at least 50%

Other

• HIV negative

• No history of concurrent severe disease that would preclude study treatment

• No other prior or concurrent malignancy except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid malignancy with no evidence of disease for at least 5 years prior to study entry

• No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent participation in another investigational drug study

• No other concurrent antineoplastic agents