Status:
COMPLETED
Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Lymphoma
Small Intestine Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, prednisone, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing o...
Detailed Description
OBJECTIVES: Primary * Compare the complete response rate (confirmed or unconfirmed) in patients with previously untreated aggressive non-Hodgkin's lymphoma treated with cyclophosphamide, doxorubicin...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of 1 of the following WHO subtypes:
- Diffuse large B large cell lymphoma (including all clinical and morphologic variants)
- Grade 3 follicular lymphoma
- Extranodal T/NK cell lymphoma, nasal type
- Enteropathy-type T cell lymphoma
- Hepato-splenic T cell lymphoma
- Peripheral T cell lymphoma, unspecified
- Angioimmunoblastic lymphoma
- Anaplastic large cell lymphoma, systemic type
- Stage II-IV disease
- At least 1 site of measurable disease (e.g., lymph node or lymph node mass)
- The following subtypes are not allowed:
- Mantle cell lymphoma
- Burkitt's lymphoma
- Precursor B or T cell lymphoma
- Primary cutaneous B or T cell lymphoma
- No CNS involvement by lymphoma
- PATIENT CHARACTERISTICS:
- Age
- 18 to 70
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- WBC \> 3,000/mm\^3
- Neutrophil count \> 1,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin \< 2.5 times normal (unless due to lymphoma)
- ALT and AST \< 2.5 times normal (unless due to lymphoma)
- Renal
- Creatinine \< 2.0 mg/dL
- Cardiovascular
- No severe cardiac disease that would preclude study participation or limit life expectancy
- Pulmonary
- FEV\_1 and DLCO ≥ 75% of predicted (unless due to lymphoma)
- No severe pulmonary disease that would preclude study participation or limit life expectancy
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No severe neurologic or metabolic disease that would preclude study participation or limit life expectancy
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent monoclonal antibodies
- Chemotherapy
- No other concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy
- No concurrent radiotherapy
- Surgery
- Not specified
- Other
- No prior cytotoxic agents
- No prior treatment for NHL
- No other concurrent anticancer therapy
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00079261
Start Date
January 1 2004
Last Update
September 24 2012
Active Locations (6)
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1
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
2
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium, 2610
3
University Hospital Rebro
Zagreb, Croatia, 41000
4
National Cancer Institute - Cairo
Cairo, Egypt