Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT00039169
Status:
UNKNOWN
Last Update Posted:
2008-07-24
First Post:
2002-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BAY 59-8862 in Treating Patients With Advanced Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C404743', 'term': 'IDN 5109'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-07-23', 'studyFirstSubmitDate': '2002-06-06', 'studyFirstSubmitQcDate': '2003-07-07', 'lastUpdatePostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-07-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['stage III renal cell cancer', 'stage IV renal cell cancer', 'recurrent renal cell cancer'], 'conditions': ['Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have advanced kidney cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Determine the overall survival in patients treated with this drug.\n* Determine the time to progression in patients treated with this drug.\n* Determine the duration of response (CR and PR) in patients treated with this drug.\n* Determine the qualitative and quantitative toxicity profile of this drug in this patient population.\n* Determine the pharmacokinetic profile of this drug in selected patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients 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.\n\nPatients are followed every 3 months until disease progression and then every 6 months thereafter or for up to 2 years.\n\nPROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed advanced renal cell cancer\n\n * Unresectable, refractory, and/or metastatic\n* At least 1 measurable lesion\n\n * A CNS lesion cannot be the sole target lesion\n * Lesions within a previously irradiated field are not considered measurable\n* 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\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9.0 g/dL\n\nHepatic:\n\n* Total bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement)\n* PT, INR, and PTT less than 1.5 times ULN\n* No chronic hepatitis B or C\n\nRenal:\n\n* Creatinine no greater than 2 times ULN\n\nCardiovascular:\n\n* No clinically evident congestive heart failure\n* No serious cardiac arrhythmias\n* No prior coronary artery disease or ischemia\n\nOther:\n\n* No prior hypersensitivity to taxane compounds that was not considered clinically manageable with premedication\n* 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)\n* No substance abuse or medical, psychological, or social conditions that would preclude study compliance\n* No active clinically serious infections\n* No other condition that is unstable or would preclude study participation\n* No grade 2 or greater pre-existing peripheral neuropathy\n* No history of seizure disorder\n\n * Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months\n* HIV negative\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 months since prior bone marrow or peripheral blood stem cell transplantation\n* No more than 2 prior immunotherapy regimens (interleukin-2 or interferon only)\n* At least 4 weeks since prior immunotherapy\n* At least 3 weeks since prior biologic response modifiers (e.g., filgrastim \\[G-CSF\\])\n* More than 4 weeks since prior thalidomide or bevacizumab\n* No prior anticancer vaccines\n* No concurrent prophylactic G-CSF\n* Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed\n* Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months before study\n\nChemotherapy:\n\n* No prior systemic cytotoxic chemotherapy\n* No prior oxaliplatin\n* No other concurrent anticancer chemotherapy\n\nEndocrine therapy:\n\n* Patients with prior metastatic brain or meningeal tumors:\n\n * No concurrent acute or tapered steroid therapy\n * Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies\n* No hormonal therapy for renal cell cancer\n\nRadiotherapy:\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy\n* No prior radiotherapy to target lesion identified for this study unless progression within the radiation portal is documented\n* Concurrent palliative radiotherapy allowed provided:\n\n * No progressive disease\n * No more than 10% of bone marrow is irradiated\n * Radiation field does not encompass a target lesion\n* No other concurrent radiotherapy\n\nSurgery:\n\n* At least 4 weeks since prior surgery\n* No prior organ allograft\n\nOther:\n\n* At least 4 weeks since prior investigational drugs\n* No other concurrent investigational therapy or approved anticancer therapy\n* No concurrent illicit drugs or other substances that would preclude study\n* Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT\n* Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints\n* Concurrent bisphosphonates for prophylaxis or bone metastases allowed'}, 'identificationModule': {'nctId': 'NCT00039169', 'briefTitle': 'BAY 59-8862 in Treating Patients With Advanced Kidney Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'An Uncontrolled Phase II Multi-Center Trial Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Advanced Renal Cell Cancer', 'orgStudyIdInfo': {'id': 'CDR0000069359'}, 'secondaryIdInfos': [{'id': 'THERADEX-100386'}, {'id': 'BAYER-100386'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ortataxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '47303', 'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'facility': 'Medical Consultants', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Marlene & Stewart Greenebaum Cancer Center, University of Maryland', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20770', 'city': 'Greenbelt', 'state': 'Maryland', 'country': 'United States', 'facility': '206 Research Associates', 'geoPoint': {'lat': 39.00455, 'lon': -76.87553}}, {'zip': '63110-0250', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University Health Sciences Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'Billings Oncology Associates', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York - Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Marius Moscovici, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pharma-Clinical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theradex', 'class': 'INDUSTRY'}}}}