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

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