Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-01-03 @ 6:58 PM
Study NCT ID:
NCT00043095
Status:
COMPLETED
Last Update Posted:
2008-07-24
First Post:
2002-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C430592', 'term': 'ixabepilone'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-04', 'lastUpdateSubmitDate': '2008-07-23', 'studyFirstSubmitDate': '2002-08-05', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2008-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.\n\nPURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with gemcitabine in treating patients who have advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose, dose-limiting toxicity, and safety of BMS-247550 when combined with gemcitabine in patients with advanced solid tumors.\n* Determine the plasma pharmacokinetics of this regimen in this patient population.\n* Assess, preliminarily, any antitumor activity of this regimen in this patient population.\n\nOUTLINE: This is a dose-escalation study of BMS-247550.\n\nPatients receive gemcitabine IV over 90 minutes on days 1 and 8 followed by BMS-247550 IV over 3 hours on day 8. The order of chemotherapy drug administration on day 8 is reversed during the second course only. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 9 patients total are treated at the MTD.\n\nPROJECTED ACCRUAL: A maximum of 40 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 non-hematological cancer that is unresponsive to currently available therapies or for which there is no known effective treatment\n* Clinical or radiological evidence of disease required\n* No active brain metastases, including evidence of cerebral edema (by CT scan or MRI), progression from prior imaging study, any requirement for steroids, or clinical symptoms\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 3 months\n\nHematopoietic\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin at least 8.0 g/dL\n\nHepatic\n\n* Bilirubin no greater than 1.5 mg/dL\n* ALT and AST no greater than 2.5 times upper limit of normal (ULN) or 93 U/L\n\nRenal\n\n* Creatinine no greater than 1.5 times ULN or 2.0 mg/dL\n\nOther\n\n* No documented hypersensitivity reaction to prior paclitaxel or other therapy containing Cremophor EL\n* No grade 2 or greater pre-existing peripheral neuropathy\n* No serious uncontrolled medical disorder or active infection that would preclude study therapy\n* No dementia or altered mental status that would preclude informed consent\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 4 weeks since prior immunotherapy\n\nChemotherapy\n\n* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)\n* Prior taxanes allowed\n* Prior adjuvant or neoadjuvant chemotherapy allowed\n* No more than 2 prior chemotherapy regimens in the metastatic setting\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* No concurrent hormonal therapy except hormone-replacement therapy\n* Concurrent medications to maintain castrate status for progressive hormone-refractory prostate cancer allowed\n\nRadiotherapy\n\n* At least 4 weeks since prior radiotherapy\n* No prior radiotherapy to more than 25% of bone marrow\n* No concurrent radiotherapy\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 4 weeks since prior investigational agents\n* No other concurrent experimental anticancer medications\n* No concurrent alternative therapies (e.g., high-dose vitamins or herbal medicines)\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00043095', 'briefTitle': 'BMS-247550 and Gemcitabine in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial of BMS 247550 (NSC# 710428) and Gemcitabine in Patients With Advanced Solid Tumor Malignancies', 'orgStudyIdInfo': {'id': 'CDR0000256333'}, 'secondaryIdInfos': [{'id': 'MSKCC-02012'}, {'id': 'NCI-5696'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gemcitabine hydrochloride', 'type': 'DRUG'}, {'name': 'ixabepilone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sibyl Anderson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}