Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT00317434
Status:
TERMINATED
Last Update Posted:
2009-12-15
First Post:
2006-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000077341', 'term': 'Lapatinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-11'}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-10', 'studyFirstSubmitDate': '2006-04-20', 'studyFirstSubmitQcDate': '2006-04-20', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD of Lapatinib measured in cohorts of 3-6 patients each'}], 'secondaryOutcomes': [{'measure': 'Clinical response rate defined by RECIST and CA125 values'}, {'measure': 'EGRF, ErbB-2, PTEN and K-ras expression in tissue samples'}, {'measure': "Correlate serum levels of Lapatinib with AE's & efficacy"}]}, 'conditionsModule': {'keywords': ['ovarian cancer'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '18692224', 'type': 'RESULT', 'citation': 'Kimball KJ, Numnum TM, Kirby TO, Zamboni WC, Estes JM, Barnes MN, Matei DE, Koch KM, Alvarez RD. A phase I study of lapatinib in combination with carboplatin in women with platinum sensitive recurrent ovarian carcinoma. Gynecol Oncol. 2008 Oct;111(1):95-101. doi: 10.1016/j.ygyno.2008.07.001. Epub 2008 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologic diagnosis of epithelial ovarian or primary peritoneal cancer\n* Measurable disease or evaluable disease with CA125 \\>100\n* One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed\n* Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy\n* 19 years of age or older\n* Life expectancy of greater than 12 weeks\n* Performance status of 0, 1 or 2 (based on GOG Performance Status)\n* Normal bone marrow, renal and hepatic function based upon lab tests\n* Cardiac ejection fraction within institutional normal range\n* Ability to swallow and retain oral medication\n* Ability to understand a written informed consent document\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study\n* Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin\n* Non-measurable or non-evaluable disease\n* Archived tumor tissue not available for assay\n* Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines\n* Patients with known brain metastases\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Uncontrolled inter-current illness\n* Patients who are pregnant\n* HIV-positive patients receiving combination anti-retroviral therapy\n* Patients with GI tract disease resulting in an inability to take oral medication'}, 'identificationModule': {'nctId': 'NCT00317434', 'briefTitle': 'Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'UAB 0538 - F051025014'}, 'secondaryIdInfos': [{'id': '104239'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'lapatinib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '48202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Ronald D. Alvarez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Ronald D. Alvarez, M.D. / Director, Professor - Gynecologic Oncology', 'oldOrganization': 'University of Alabama at Birmingham'}}}}