Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-01 @ 6:32 PM
Study NCT ID:
NCT00287859
Status:
TERMINATED
Last Update Posted:
2017-11-29
First Post:
2006-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube 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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Withdrawn due to low accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2006-02-06', 'studyFirstSubmitQcDate': '2006-02-06', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fallopian tube cancer', 'peritoneal cavity cancer', 'recurrent ovarian epithelial cancer'], 'conditions': ['Fallopian Tube Cancer', 'Ovarian Cancer', 'Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemotherapy drugs may have different effects in patients who have a poor performance status.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the maximum tolerated dose of weekly topotecan in patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer and a poor performance status.\n\nSecondary\n\n* Estimate the response rate of women with poor performance status for use in future clinical trials.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6 patients will be treated at the MTD.\n\nPatients are followed periodically for up to 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer\n\n * Progressive or recurrent disease\n* Received ≥ 1 prior course of chemotherapy\n* Measurable or evaluable disease OR disease assessable by CA 125, defined as CA 125 \\> normal that has increased over 2 readings \\> 14 days apart\n* Karnofsky performance status 10-50%\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n* Creatinine ≤ 1.5 mg/dL\n* Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 times ULN\n* SGOT ≤ 3 times ULN\n* Life expectancy ≥ 12 weeks\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use accepted and effective non-hormonal contraception\n\nExclusion Criteria:\n\n* Other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy\n* Septicemia, severe infection, or acute hepatitis\n* Severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization'}, 'identificationModule': {'nctId': 'NCT00287859', 'briefTitle': 'Topotecan in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Phase I Study of Weekly Topotecan in Women With Progressive or Recurrent Ovarian Cancer and a Poor Performance Status', 'orgStudyIdInfo': {'id': '2004LS039'}, 'secondaryIdInfos': [{'id': 'UMN-WCC-39', 'type': 'OTHER', 'domain': "Women's Cancer Center, University of Minnesota"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Escalating Cohorts', 'description': 'Patients receive topotecan intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6 patients will be treated at the MTD.', 'interventionNames': ['Drug: topotecan hydrochloride']}], 'interventions': [{'name': 'topotecan hydrochloride', 'type': 'DRUG', 'otherNames': ['Hycamtin(R)'], 'description': 'intravenously (IV) over 30 minutes on days 1, 8, 15, 22, and 29.', 'armGroupLabels': ['Escalating Cohorts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Levi S. Downs, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Levi Downs, Jr, MD', 'oldOrganization': 'Masonic Cancer Center, University of Minnesota'}}}}