Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-21 @ 1:02 PM
Study NCT ID:
NCT00111904
Status:
COMPLETED
Last Update Posted:
2011-12-14
First Post:
2005-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708971', 'term': 'genexol-PM'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'lastUpdateSubmitDate': '2011-12-13', 'studyFirstSubmitDate': '2005-05-26', 'studyFirstSubmitQcDate': '2005-05-26', 'lastUpdatePostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Time to treatment failure'}, {'measure': 'Best overall response rate'}, {'measure': 'Overall survival'}, {'measure': 'Clinical benefit'}, {'measure': 'Safety'}]}, 'conditionsModule': {'keywords': ['stage III pancreatic cancer', 'recurrent pancreatic cancer', 'stage IV pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '19968498', 'type': 'RESULT', 'citation': 'Saif MW, Podoltsev NA, Rubin MS, Figueroa JA, Lee MY, Kwon J, Rowen E, Yu J, Kerr RO. Phase II clinical trial of paclitaxel loaded polymeric micelle in patients with advanced pancreatic cancer. Cancer Invest. 2010 Feb;28(2):186-94. doi: 10.3109/07357900903179591.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.\n\nPURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol\\^®-PM).\n* Determine the best overall response rate and duration of response in patients treated with this drug.\n* Determine the overall survival of patients treated with this drug.\n* Determine the clinical benefit and safety of this drug in these patients.\n\nOUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol\\^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 43 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 epithelial carcinoma of the pancreas\n\n * Unresectable\\* locally advanced or metastatic disease NOTE: \\*Documented by high-quality contrast-enhanced CT scan\n* No known or clinical evidence of CNS metastasis\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ\n* No unstable or serious medical condition\n* No psychiatric disorder that would preclude giving informed consent\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for pancreatic cancer\n\n * Prior fluorouracil as a radiosensitizer allowed\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* More than 6 weeks since prior radiotherapy for pancreatic cancer\n\n * Disease must have progressed after completion of radiotherapy\n\nSurgery\n\n* More than 14 days since prior major surgery and recovered\n\nOther\n\n* More than 30 days since prior investigational agents'}, 'identificationModule': {'nctId': 'NCT00111904', 'briefTitle': 'Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer', 'orgStudyIdInfo': {'id': 'CDR0000433513'}, 'secondaryIdInfos': [{'id': 'TARGET-S04-10485'}, {'id': 'WIRB-20050099'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'paclitaxel-loaded polymeric micelle', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34135', 'city': 'Bonita Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Bonita Springs', 'geoPoint': {'lat': 26.33981, 'lon': -81.7787}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwest Cancer Research Group, Incorporated', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '70506', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Oncology Associates - Lafayette', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Vincent's Comprehensive Cancer Center - Manhattan", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Regional Cancer Center - Central', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'John S. MacDonald, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beth Israel Comprehensive Cancer Center - West Side Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theradex', 'class': 'INDUSTRY'}}}}