BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate:
• •* Diffuse large B-cell lymphoma
• •* Transformed NHL
• •* Follicular large cell lymphoma
• •* Peripheral T cell lymphoma
• •* Anaplastic large cell lymphoma
• •* Mantle cell lymphoma
• •* Unclassified aggressive histology
• •* Immunoblastic lymphoma
• •Failed at least 1 prior therapy (primary resistant) OR
• •Previously achieved a remission and then progressed or relapsed within 6 months of therapy
• •At least 1 bidimensionally measurable lesion
• •* Lesions within a previously irradiated field are not considered measurable
• •No relapse within 6 months after prior autologous bone marrow transplantation
• •No prior allogeneic bone marrow or stem cell transplantation or post-transplant lymphoproliferative disorder
• •No parenchymal or meningeal CNS involvement unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •ECOG 0-2
• •Life expectancy:
• •At least 12 weeks
• •Hematopoietic:
• •Absolute neutrophil count at least 1,500/mm\^3
• •Platelet count at least 75,000/mm\^3
• •Hemoglobin at least 9.0 g/dL
• •Hepatic:
• •Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement)
• •PT, INR, and PTT less than 1.5 times ULN
• •No chronic hepatitis B or C
• •Renal:
• •Creatinine no greater than 1.5 times ULN
• •Cardiovascular:
• •No clinically evident congestive heart failure
• •No New York Heart Association class III or IV heart disease
• •No serious cardiac arrhythmias
• •No active coronary artery disease or ischemia
• •Other:
• •No prior hypersensitivity to taxane compounds
• •No known or suspected allergy to the investigational study agent or any agent given in association with this study
• •No other prior or concurrent malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the bladder or cervix (adequately cone biopsied)
• •No substance abuse or medical, psychological, or social conditions that would preclude study participation
• •No active clinically serious infections
• •No other condition that is unstable or would preclude study participation
• •No grade 2 or greater pre-existing peripheral neuropathy
• •No history of seizure disorder
• •* Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months
• •HIV negative
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •See Disease Characteristics
• •See Chemotherapy
• •At least 4 weeks since prior anticancer immunotherapy
• •At least 3 weeks since prior biologic response modifiers (e.g., filgrastim \[G-CSF\])
• •No concurrent anticancer immunotherapy
• •No concurrent prophylactic G-CSF
• •Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed
• •Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months prior to study
• •Chemotherapy:
• •See Disease Characteristics
• •At least 4 weeks since prior anticancer chemotherapy
• •No more than 3 prior systemic chemotherapy regimens for metastatic NHL:
• •* High-dose therapy for autologous hematopoietic stem cell transplantation (SCT) is considered 1 prior regimen
• •* Salvage chemotherapy followed by autologous bone marrow transplant or peripheral SCT is considered 1 prior regimen
• •* Antibody treatment is not considered 1 prior regimen
• •No prior taxanes or oxaliplatin
• •No other concurrent anticancer chemotherapy
• •Endocrine therapy:
• •Patients with prior parenchymal or meningeal CNS involvement:
• •* No concurrent acute or tapered steroid therapy
• •* Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies
• •Radiotherapy:
• •See Disease Characteristics
• •At least 4 weeks since prior radiotherapy
• •Concurrent palliative radiotherapy allowed provided:
• •* No progressive disease
• •* No more than 10% of bone marrow is irradiated
• •* Radiation field does not encompass a target lesion
• •No other concurrent radiotherapy
• •Surgery:
• •At least 4 weeks since prior major surgery
• •Other:
• •At least 4 weeks since prior investigational drugs
• •No other concurrent investigational therapy or approved anticancer therapy
• •No concurrent illicit drugs or other substances that would preclude study
• •Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT
• •Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints
• •Concurrent bisphosphonates for prophylaxis or bone metastases allowed