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An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma


- Determine the overall tumor response rate, including complete response (CR) and partial
response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma
treated with BAY 59-8862.

- Determine the overall survival in patients treated with this drug.

- Determine the time to progression in patients treated with this drug.

- Determine the duration of response (CR and PR) in patients treated with this drug.

- Determine the qualitative and quantitative toxicity profile of this drug in this
patient population.

- Determine the pharmacokinetic profile of this drug in selected patients.

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.

Inclusion Criteria


- 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

- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 75,000/mm^3

- Hemoglobin at least 9.0 g/dL


- 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


- Creatinine no greater than 1.5 times ULN


- 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


- 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


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


- 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


- 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


- At least 4 weeks since prior major surgery


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Rasim Ahmet Gucalp, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Montefiore Medical Center


United States: Federal Government

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin



University of Chicago Cancer Research Center Chicago, Illinois  60637
State University of New York - Upstate Medical University Syracuse, New York  13210
Medical College of Wisconsin Milwaukee, Wisconsin  53226
New York Medical College Valhalla, New York  10595
North Shore University Hospital Manhasset, New York  11030
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Albert Einstein Clinical Cancer Center Bronx, New York  10461
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida  33140
HemOnCare, P.C. Brooklyn, New York  11235
Seattle Cancer Care Alliance Seattle, Washington  98109
West Clinic Memphis, Tennessee  38117