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

Lymphoma Clinical Trial

Official title:

Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039351
• Other study ID #: EORTC-20992
• Secondary ID: EORTC-20992
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2002
• Last updated: September 20, 2012
• Start date: March 2002

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 tumor cells.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• cyclophosphamide

• prednisone

• vincristine sulfate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Belgium	Ziekenhuis Network Antwerpen Middelheim	Antwerp
Belgium	Centre Hospitalier Universitaire Brugmann	Brussels
Belgium	U.Z. Gasthuisberg	Leuven
Egypt	National Cancer Institute of Egypt	Cairo
France	Centre D'Oncologie Du Pays-Basque	Bayonne
France	Hopital Saint Andre	Bordeaux
France	Institut Bergonie	Bordeaux
France	Centre Hospitalier de Dax	Dax
France	Hopital Robert Boulin	Libourne
France	Polyclinique de Francheville	Perigueux
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Academisch Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Nijmegen	Nijmegen
Portugal	Hospitais da Universidade de Coimbra (HUC)	Coimbra
Switzerland	Hopitaux Universitaires de Geneve	Thonex-Geneve
United Kingdom	Dumfries Royal Infirmary	Dumfries
United Kingdom	New Cross Hospital	Wolverhampton	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Egypt,  France,  Netherlands,  Portugal,  Switzerland,  United Kingdom,