Clinical trial NCT00039351: Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: stage I adult diffuse large cell lymphoma
stage III adult diffuse large cell lymphoma
stage IV adult diffuse large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
angioimmunoblastic T-cell lymphoma
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-01-27
Enrollment: 32
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Ziekenhuis Network Antwerpen Middelheim
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Brugmann
city: Leuven
country: Belgium
facility: U.Z. Gasthuisberg
city: Cairo
country: Egypt
facility: National Cancer Institute of Egypt
city: Bayonne
country: France
facility: Centre D'Oncologie Du Pays-Basque
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Bordeaux
country: France
facility: Institut Bergonie
city: Dax
country: France
facility: Centre Hospitalier de Dax
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Perigueux
country: France
facility: Polyclinique de Francheville
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra (HUC)
city: Thonex-Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Dumfries
country: United Kingdom
facility: Dumfries Royal Infirmary
Study officials:
affiliation: Institut Bergonié
name: Pierre Soubeyran, MD, PhD
role: STUDY_CHAIR
References: