An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter, open-label study.
Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years.
PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate:
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
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:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
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
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
See Disease Characteristics
At least 4 weeks since prior anticancer chemotherapy
No more than 3 prior systemic chemotherapy regimens for metastatic NHL:
No prior taxanes or oxaliplatin
No other concurrent anticancer chemotherapy
Endocrine therapy:
Patients with prior parenchymal or meningeal CNS involvement:
Radiotherapy:
See Disease Characteristics
At least 4 weeks since prior radiotherapy
Concurrent palliative radiotherapy allowed provided:
No other concurrent radiotherapy
Surgery:
Other:
Shreveport, Louisiana 71130-3932, United States