BAY 59-8862 in Treating Patients With Advanced Kidney Cancer

NCT00039169 | Unknown Phase 2

• 3 other identifiers: CDR0000069359THERADEX-100386BAYER-100386
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 13

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.

Conditions

Kidney Cancer

Keywords

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

Interventions

ortataxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Theradex: lead

Study Sites (13)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Medical Consultants

Muncie, Indiana, 47303, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

206 Research Associates

Greenbelt, Maryland, 20770, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Billings Oncology Associates

Billings, Montana, 59101, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

IDN 5109

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Marius Moscovici, MD

  Pharma-Clinical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: July 8, 2003
• Study Start: December 1, 2001
• Last Updated: July 24, 2008

Record last verified: 2008-01

Locations

CA (2); US (11)