Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-02 @ 3:19 PM
Study NCT ID:
NCT00072267
Status:
COMPLETED
Last Update Posted:
2015-07-23
First Post:
2003-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube 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': 'C054852', 'term': '7-hydroxystaurosporine'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2003-11-04', 'studyFirstSubmitQcDate': '2003-11-05', 'lastUpdatePostDateStruct': {'date': '2015-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV ovarian epithelial cancer', 'recurrent ovarian epithelial cancer', 'primary peritoneal cavity cancer', 'fallopian tube cancer', 'stage III ovarian epithelial cancer'], 'conditions': ['Fallopian Tube Cancer', 'Ovarian Cancer', 'Primary Peritoneal Cavity Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.\n\nPURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.\n\nSecondary\n\n* Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.\n* Determine the progression-free, median, and overall survival of patients treated with this regimen.\n* Determine the safety and tolerability of this regimen in these patients.\n* Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer\n\n * Progressive, persistent, or recurrent disease\n* Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy\n* Tumor lesions accessible for biopsy\n\n * Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator\n* No more than 2 prior chemotherapy regimens\n\n * At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin)\n* No known brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2 OR\n* Karnofsky 60-100%\n\nLife expectancy\n\n* More than 12 weeks\n\nHematopoietic\n\n* WBC at least 3,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* AST/ALT no greater than 2.5 times ULN\n\nRenal\n\n* Creatinine no greater than ULN OR\n* Creatinine clearance at least 50 mL/min\n\nCardiovascular\n\n* No history of coronary artery disease\n* No symptomatic cardiac dysfunction\n* No cardiac pathology by electrocardiogram\\* NOTE: \\*Patients with symptomatic coronary artery disease must undergo an electrocardiogram\n\nPulmonary\n\n* No symptomatic pulmonary dysfunction\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 8 weeks after study participation\n* No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents\n* No insulin-dependent diabetes mellitus\n\n * Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator\n* No other concurrent uncontrolled illness\n* No ongoing or active infection\n* No psychiatric illness or social situation that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 4 weeks since prior biologic therapy and recovered\n\nChemotherapy\n\n* See Disease Characterisitcs\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n* No prior topotecan\n* No other prior topoisomerase I inhibitors\n\nEndocrine therapy\n\n* More than 4 weeks since prior hormonal therapy and recovered\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy and recovered\n* No prior radiotherapy to more than 40% of bone marrow\n* No prior mediastinal irradiation\n\nSurgery\n\n* More than 4 weeks since prior surgery and recovered\n\nOther\n\n* No other concurrent anticancer therapy\n* No other concurrent investigational agents\n* No concurrent combination antiretroviral therapy for HIV-positive patients'}, 'identificationModule': {'nctId': 'NCT00072267', 'briefTitle': 'UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer', 'orgStudyIdInfo': {'id': 'PMH-PHL-019'}, 'secondaryIdInfos': [{'id': 'CDR0000339563', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-6402'}]}, 'armsInterventionsModule': {'interventions': [{'name': '7-hydroxystaurosporine', 'type': 'DRUG'}, {'name': 'topotecan hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Margaret and Charles Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Hal W. Hirte, MD, FRCP(C)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Margaret and Charles Juravinski Cancer Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}