Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-27 @ 4:29 AM
Study NCT ID:
NCT00429559
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2007-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2007-01-30', 'studyFirstSubmitQcDate': '2007-01-30', 'lastUpdatePostDateStruct': {'date': '2011-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan.', 'timeFrame': '1year'}], 'secondaryOutcomes': [{'measure': 'Toxicity profile', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Cancer;', 'Ovarian cancer;', 'Recurrent ovarian cancer platinum-resistant'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly in patients with platinum -resistant ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed ovarian adenocarcinoma\n* Patients had to have received a front-line, platinum- based chemotherapy regimen\n* Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer. This category also will include patients with disease progression within six months of completing the most recent platinum-based chemotherapy\n* Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area, or increased Ca 125\n* A \\>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment\n* Age \\> 18 years old\n* Performance status (WHO) 0-2\n* Life expectancy of at least three months\n* Adequate bone marrow function (absolute neutrophil count \\> 1000/mm\\^3, platelet count \\> 100000/mm\\^3, hemoglobin \\> 9 gr/mm\\^3)\n* Adequate liver (bilirubin \\< 1.5 times upper limit of normal and SGOT/SGPT \\< 2 times upper limit of normal) and renal function (creatinine \\< 2 mg/dl)\n* Informed consent\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Psychiatric illness or social situation that would preclude study compliance\n* Other concurrent uncontrolled illness\n* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer'}, 'identificationModule': {'nctId': 'NCT00429559', 'briefTitle': 'Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'Weekly Administration of Topotecan in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer', 'orgStudyIdInfo': {'id': 'CT/06.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Hycamptin', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Hycamptin', 'type': 'DRUG', 'otherNames': ['Topotecan'], 'description': '1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression', 'armGroupLabels': ['A']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar'], 'description': 'Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks.\n\nNumber of cycles: until progression', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University Hospital of Crete', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Dep of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"IASO" General Hospital of Athnes, Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Larissa', 'country': 'Greece', 'facility': 'State General Hospital of Larissa, Dep of Medical Oncology', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': '"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Antonia Kalikaki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Crete, Dep of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'A.Kalykaki', 'oldOrganization': 'Hellenic Oncology Research Group'}}}}