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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00039351

Collaborator

(none)

Enrollment

Locations

1.9

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: cyclophosphamide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Mar 1, 2002

Actual Primary Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ziekenhuis Network Antwerpen Middelheim	Antwerp		Belgium	2020
2	Centre Hospitalier Universitaire Brugmann	Brussels		Belgium	B 1020
3	U.Z. Gasthuisberg	Leuven		Belgium	B-3000
4	National Cancer Institute of Egypt	Cairo		Egypt
5	Centre D'Oncologie Du Pays-Basque	Bayonne		France	F-64100
6	Hopital Saint Andre	Bordeaux		France	33075
7	Institut Bergonie	Bordeaux		France	33076
8	Centre Hospitalier de Dax	Dax		France	40107
9	Hopital Robert Boulin	Libourne		France	33500
10	Polyclinique de Francheville	Perigueux		France	24004
11	Onze Lieve Vrouwe Gasthuis	Amsterdam		Netherlands	1091 HA
12	Academisch Ziekenhuis Groningen	Groningen		Netherlands	9700 RB
13	University Medical Center Nijmegen	Nijmegen		Netherlands	NL-6500 HB
14	Hospitais da Universidade de Coimbra (HUC)	Coimbra		Portugal	3001-301
15	Hopitaux Universitaires de Geneve	Thonex-Geneve		Switzerland	CH-1226
16	New Cross Hospital	Wolverhampton	England	United Kingdom	WV10 0QP
17	Dumfries Royal Infirmary	Dumfries		United Kingdom	DG1 4AP