Clinical trial NCT00039169: BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
Official title: An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-07-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 advanced kidney cancer.

Detailed description: OBJECTIVES:

* Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with advanced renal cell cancer 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 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 or for up to 2 years.

PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed advanced renal cell cancer

  * Unresectable, refractory, and/or metastatic
* At least 1 measurable lesion

  * A CNS lesion cannot be the sole target lesion
  * Lesions within a previously irradiated field are not considered measurable
* No metastatic brain or meningeal tumors 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 100,000/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 2 times ULN

Cardiovascular:

* No clinically evident congestive heart failure
* No serious cardiac arrhythmias
* No prior coronary artery disease or ischemia

Other:

* No prior hypersensitivity to taxane compounds that was not considered clinically manageable with premedication
* No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1)
* No substance abuse or medical, psychological, or social conditions that would preclude study compliance
* 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:

* At least 4 months since prior bone marrow or peripheral blood stem cell transplantation
* No more than 2 prior immunotherapy regimens (interleukin-2 or interferon only)
* At least 4 weeks since prior immunotherapy
* At least 3 weeks since prior biologic response modifiers (e.g., filgrastim \[G-CSF\])
* More than 4 weeks since prior thalidomide or bevacizumab
* No prior anticancer vaccines
* 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 before study

Chemotherapy:

* No prior systemic cytotoxic chemotherapy
* No prior oxaliplatin
* No other concurrent anticancer chemotherapy

Endocrine therapy:

* Patients with prior metastatic brain or meningeal tumors:

  * 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
* No hormonal therapy for renal cell cancer

Radiotherapy:

* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to target lesion identified for this study unless progression within the radiation portal is documented
* 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 surgery
* No prior organ allograft

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Muncie
country: United States
facility: Medical Consultants
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland
state: Maryland
city: Greenbelt
country: United States
facility: 206 Research Associates
state: Maryland
city: Saint Louis
country: United States
facility: St. Louis University Health Sciences Center
state: Missouri
city: Billings
country: United States
facility: Billings Oncology Associates
state: Montana
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: Syracuse
country: United States
facility: State University of New York - Upstate Medical University
state: New York
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Center - Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Pharma-Clinical
name: Marius Moscovici, MD
role: STUDY_CHAIR
References: