Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-02 @ 2:05 PM
Study NCT ID:
NCT00003892
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C099587', 'term': 'ISIS 5132'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2008-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-08-04', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective and duration of response', 'timeFrame': '9 years', 'description': 'To determine the efficacy of ISIS 5132 in patients with recurrent epithelial ovarian cancer, with evaluation of objective responses and duration of responses in patients receiving this compound in a phase II trial.'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '9 years', 'description': 'To determine the tolerability and quantitative toxicity of ISIS 5132 when given to patients with recurrent ovarian cancer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage IV ovarian epithelial cancer', 'recurrent ovarian epithelial cancer'], 'conditions': ['Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '12694666', 'type': 'RESULT', 'citation': 'Oza AM, Elit L, Swenerton K, Faught W, Ghatage P, Carey M, McIntosh L, Dorr A, Holmlund JT, Eisenhauer E; NCIC Clinical Trials Group Study (NCIC IND.116). Phase II study of CGP 69846A (ISIS 5132) in recurrent epithelial ovarian cancer: an NCIC clinical trials group study (NCIC IND.116). Gynecol Oncol. 2003 Apr;89(1):129-33. doi: 10.1016/s0090-8258(02)00144-0.'}]}, '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 ISIS 5132 in treating patients who have metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.', 'detailedDescription': 'OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the tolerability and quantitative toxicity of ISIS 5132 in this patient population.\n\nOUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses. Patients with documented partial response receive an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease relapse or progression.\n\nPROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically documented ovarian epithelial cancer Metastatic and/or locally recurrent disease that is incurable with standard therapy Must have received 1 or 2 prior regimens of chemotherapy At least 1 regimen must have contained cisplatin or carboplatin Bidimensionally measurable disease Indicator lesion size must be as follows: At least 4-50 cm2 by CT scan At least 1 cm2 by chest xray At least 1 cm2 (e.g., nodules) by physical exam No abdominal adenocarcinoma of unknown origin No borderline ovarian tumor No tumor known to be of primary fallopian tube or peritoneal origin\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 No known bleeding disorder Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST less than 5 times ULN PT/PTT normal (except when elevated due to therapeutic coumadin) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No significant cardiac dysfunction Neurologic No history of significant neurologic disorder No significant psychiatric disorder Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy and no evidence of recurrence No other serious illness or medical condition No active uncontrolled infection No complete bowel obstruction\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No other concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior radiotherapy At least 4 weeks since radiotherapy to at least 20% of bone marrow Surgery: Not specified Other: As least 28 days since prior investigational agent or new anticancer therapy No concurrent therapeutic heparin No other concurrent investigational therapy'}, 'identificationModule': {'nctId': 'NCT00003892', 'briefTitle': 'ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer', 'orgStudyIdInfo': {'id': 'I116'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-IND116', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'CDR0000067061', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISIS 5132', 'description': 'ISIS 5132 x 21 days IV infusion', 'interventionNames': ['Drug: ISIS 5132']}], 'interventions': [{'name': 'ISIS 5132', 'type': 'DRUG', 'description': '4mg/kg/day IV for 21 days every 4 weeks.', 'armGroupLabels': ['ISIS 5132']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Duluth Clinic', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T1J 1W5', 'city': 'Lethbridge', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Lethbridge Cancer Clinic', 'geoPoint': {'lat': 49.69999, 'lon': -112.81856}}, {'zip': 'V5H 4C2', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Burnaby Hospital Regional Cancer Centre', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'zip': 'V2A 3G6', 'city': 'Penticton', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Penticton Regional Hospital', 'geoPoint': {'lat': 49.48062, 'lon': -119.58584}}, {'zip': 'V3V 1Z2', 'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Fraser Valley Cancer Centre', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V5Z 3J5', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Prostate Centre at Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital - Vancouver", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 1J8', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency - Vancouver Island Cancer Centre', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E1C 6ZB', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Moncton Hospital', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'E1C 8X3', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Doctor Leon Richard Oncology Centre', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Dr. H. Bliss Murphy Cancer Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Cancer Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II Health Science Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L4M 6M2', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Royal Victoria Hospital, Barrie', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'L6W 2Z8', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Peel Memorial Hospital', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'P3E 5J1', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northeastern Ontario Regional Cancer Centre, Sudbury', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-Hamilton Regional Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 5P9', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Regional Cancer Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'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': 'L5B 1B8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Trillium Health Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 2N1', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley Hospital', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'York County Hospital', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M2E 1K1', 'city': 'North York', 'state': 'Ontario', 'country': 'Canada', 'facility': 'North York General Hospital, Ontario'}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lakeridge Health Oshawa', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Center - General Division', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K1Y 4K7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre - Civic Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K9H 7B6', 'city': 'Peterborough', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Peterborough Oncology Clinic', 'geoPoint': {'lat': 44.30012, 'lon': -78.31623}}, {'zip': 'P6B 1Y5', 'city': 'Sault Ste. Marie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Algoma District Medical Group', 'geoPoint': {'lat': 46.51677, 'lon': -84.33325}}, {'zip': 'M1P 2V5', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Scarborough Hospital - General Site', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'L2R 5K3', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital - St. Catharines', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'P7A 7T1', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northwestern Ontario Regional Cancer Centre, Thunder Bay', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4C 3E9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto East General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital - 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Oza, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Margaret Hospital, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}