Combination Chemotherapy in Treating Older Patients With Non-Hodgkin's Lymphoma
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: cyclophosphamide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
| Enrollment: | 32 |
| Study Start Date: | March 2002 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Belgium | |
| Ziekenhuis Network Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| Centre Hospitalier Universitaire Brugmann | |
| Brussels, Belgium, B 1020 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Egypt | |
| National Cancer Institute of Egypt | |
| Cairo, Egypt | |
| France | |
| Centre D'Oncologie Du Pays-Basque | |
| Bayonne, France, F-64100 | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Hopital Saint Andre | |
| Bordeaux, France, 33075 | |
| Centre Hospitalier de Dax | |
| Dax, France, 40107 | |
| Hopital Robert Boulin | |
| Libourne, France, 33500 | |
| Polyclinique de Francheville | |
| Perigueux, France, 24004 | |
| Netherlands | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Academisch Ziekenhuis Groningen | |
| Groningen, Netherlands, 9700 RB | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Portugal | |
| Hospitais da Universidade de Coimbra (HUC) | |
| Coimbra, Portugal, 3001-301 | |
| Switzerland | |
| Hopitaux Universitaires de Geneve | |
| Thonex-Geneve, Switzerland, CH-1226 | |
| United Kingdom | |
| New Cross Hospital | |
| Wolverhampton, England, United Kingdom, WV10 0QP | |
| Dumfries Royal Infirmary | |
| Dumfries, United Kingdom, DG1 4AP | |
| Study Chair: | Pierre Soubeyran, MD, PhD | Institut Bergonié |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00039351 History of Changes |
| Other Study ID Numbers: | EORTC-20992, EORTC-20992 |
| Study First Received: | June 6, 2002 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Prednisone Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Anti-Inflammatory Agents Tubulin Modulators Antimitotic Agents |
ClinicalTrials.gov processed this record on May 22, 2013