BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

Kidney Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00039169
• Other study ID #: CDR0000069359
• Secondary ID: THERADEX-100386B
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 6, 2002
• Last updated: July 23, 2008
• Start date: December 2001

Study information

• Verified date: January 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• ortataxel

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Billings Oncology Associates	Billings	Montana
United States	206 Research Associates	Greenbelt	Maryland
United States	Scripps Clinic	La Jolla	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Medical Consultants	Muncie	Indiana
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Ochsner Clinic	New Orleans	Louisiana
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	State University of New York - Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Theradex

Countries where clinical trial is conducted

United States,  Canada,