Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00022620
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['recurrent endometrial carcinoma', 'endometrial papillary serous carcinoma'], 'conditions': ['Endometrial 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 paclitaxel in treating patients who have refractory or recurrent endometrial cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the therapeutic activity of paclitaxel in patients with refractory or recurrent endometrial papillary carcinoma.\n* Determine the objective response and duration of response in patients treated with this regimen.\n* Determine the acute side effects of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 12 weeks.\n\nPROJECTED ACCRUAL: Approximately 16-29 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)\n\n * Progressive or recurrent\n* Bidimensionally measurable disease\n* Platinum refractory disease, defined by one of the following:\n\n * Progression during platinum-based chemotherapy\n * Stable disease for at least 4 courses of platinum-based chemotherapy\n * Recurrence within 4 months of platinum-based chemotherapy\n* No brain involvement or leptomeningeal disease\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 75 and under\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Neutrophil count at least 1,500/mm3\n* Platelet count at least 100,000/mm3\n\nHepatic:\n\n* Bilirubin no greater than 50 umol/L\n\nRenal:\n\n* BUN no greater than 8.0 mmol/L\n* Creatinine no greater than 120 umol/L\n* Creatinine clearance at least 60 mL/min\n\nOther:\n\n* Not pregnant\n* Fertile patients must use effective contraception\n* HIV negative\n* No other prior or concurrent malignancy except basal cell carcinoma of the skin\n* No active bacterial infection (e.g., urinary tract infection)\n* No uncontrolled or potentially active site of infection (e.g., fistula or abscess)\n* No psychological, familial, sociological, or geographical condition that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy\n* At least 1 prior platinum containing regimen\n* At least 50 mg/m2 per course for a maximum of 28 days for cisplatin\n* At least 5 times AUC for a maximum of 4 weeks per course for carboplatin\n* Prior non-taxane-containing chemotherapy allowed\n\nEndocrine therapy:\n\n* At least 4 weeks since prior hormonal therapy\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n* At least 3 months since prior radiotherapy to target lesion\n* Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)\n\nSurgery:\n\n* Prior surgical management of lymph nodes allowed'}, 'identificationModule': {'nctId': 'NCT00022620', 'briefTitle': 'Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Phase II Study On Paclitaxel In Recurrent Uterine Papillary Serous Carcinoma (UPSC)', 'orgStudyIdInfo': {'id': 'EORTC-55961'}, 'secondaryIdInfos': [{'id': 'EORTC-55961'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'paclitaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus der Stadt Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '10128', 'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Mauriziano Umberto I', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '27058', 'city': 'Voghera (PV)', 'country': 'Italy', 'facility': 'Ospedale Civile', 'geoPoint': {'lat': 44.99151, 'lon': 9.01175}}, {'zip': '3049', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Hospitais da Universidade de Coimbra (HUC)', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitasrio San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'NE9 6SX', 'city': 'Gateshead', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 54.96209, 'lon': -1.60168}}], 'overallOfficials': [{'name': 'Gerald Gitsch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Allgemeines Krankenhaus - Universitatskliniken'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}