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