Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Drug: vincristine sulfate; Drug: cyclophosphamide; Drug: prednisone; Radiation: radiation therapy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00039351

EORTC-20992

Details and patient eligibility

About

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 tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.

Full description

OBJECTIVES:

• Determine the complete remission (CR) rate and duration of CR in frail elderly patients with diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma treated with cyclophosphamide, vincristine, and prednisone.
• Determine the time to progression and overall survival of patients treated with this regimen.
• Determine the severe toxicity rate of this regimen in these patients.
• Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients with stage I or II non-Hodgkin's lymphoma (NHL), no baseline lactate dehydrogenase (LDH) elevation, baseline WHO performance status 0-1, and longest tumor diameter of less than 5 cm, who achieve partial response (PR) or complete response (CR), receive 1 additional course of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.

Patients with stage I or II NHL, a baseline LDH elevation, and/or baseline WHO performance status 2-4, and/or longest tumor diameter of at least 5 cm, who achieve PR or CR, receive 3 additional courses of chemotherapy. Patients then undergo involved-field radiotherapy once daily 5 days a week for 3.5-4 weeks.

Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy. Patients then undergo consolidative radiotherapy once daily 5 days a week for 2.5-3 weeks.

Quality of life is assessed at baseline, after the third chemotherapy course, at the end of chemotherapy, every 6 months for 3 years, and then annually thereafter.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 29-56 patients will be accrued for this study within 12-18 months.

Enrollment: 32 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin's lymphoma (NHL)

  • No Burkitt's-like lymphoma
  • Small cells in bone marrow allowed

• Previously untreated NHL

• At least 1 measurable lesion

  • At least 1.1 cm

• Poor physiological status with at least 1 of the following:

  • WHO performance status of 3-4
  • LVEF less than 50%
  • Creatinine clearance less than 50 mL/min
  • Neutrophil count no greater than 1,500/mm^3
  • Platelet count no greater than 100,000/mm^3
  • Concurrent severe disease that would preclude cyclophosphamide, vincristine, prednisolone, and doxorubicin

• No cerebral or meningeal involvement

PATIENT CHARACTERISTICS:

Age:

• 70 and over

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Not specified

Renal:

• See Disease Characteristics

Other:

• HIV negative
• No other malignancy within the past 5 years except adequately treated basal cell skin cancer, curatively treated carcinoma in situ of the cervix, or curatively treated solid tumor
• No active infection
• No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent investigational drugs
• No other concurrent antineoplastic agents