An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive 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