BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

NCT ID: NCT00039169

Last Updated: 2008-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31

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.

Conditions

Kidney Cancer

Keywords

stage III renal cell cancer; stage IV renal cell cancer; recurrent renal cell cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

ortataxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theradex

INDUSTRY

Sponsor Role: lead

Principal Investigators

Marius Moscovici, MD

Role: STUDY_CHAIR

Pharma-Clinical

Locations

Scripps Clinic

La Jolla, California, United States

Medical Consultants

Muncie, Indiana, United States

Ochsner Clinic

New Orleans, Louisiana, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, United States

206 Research Associates

Greenbelt, Maryland, United States

St. Louis University Health Sciences Center

St Louis, Missouri, United States

Billings Oncology Associates

Billings, Montana, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

State University of New York - Upstate Medical University

Syracuse, New York, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

United States; Canada

Other Identifiers

THERADEX-100386

Identifier Type: -

Identifier Source: secondary_id

BAYER-100386

Identifier Type: -

Identifier Source: secondary_id

CDR0000069359

Identifier Type: -

Identifier Source: org_study_id