Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT00066456
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2003-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, 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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2003-08-06', 'studyFirstSubmitQcDate': '2003-08-06', 'lastUpdatePostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0', 'timeFrame': 'Up to 30 days after completion of radiation therapy'}], 'secondaryOutcomes': [{'measure': 'Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria version 2.0 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (CTC v2.0 RTOG/EORTC) late radiation morbidity scoring', 'timeFrame': 'Up to 5 years'}]}, 'conditionsModule': {'conditions': ['Fallopian Tube Carcinoma', 'Primary Peritoneal Carcinoma', 'Recurrent Ovarian Carcinoma', 'Stage III Ovarian Cancer', 'Stage IV Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'Phase I trial to study the effectiveness of low-dose radiation therapy to the abdomen combined with docetaxel in treating patients who have recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.', 'detailedDescription': 'OBJECTIVES:\n\nI. Determine the maximum tolerated dose of docetaxel in combination with low-dose abdominal radiotherapy in patients with recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer.\n\nII. Determine the safety and toxicity of this regimen in these patients.\n\nOUTLINE: This is a multicenter, dose-escalation study of docetaxel.\n\nPatients receive docetaxel IV over 30 minutes once daily on days 1, 8, 15, 22, 29, and 35. Within 3 hours after beginning docetaxel, patients also receive low-dose abdominal radiotherapy twice daily (at least 4 hours apart) on days 1, 2, 8, 9, 15, 16, 22, 24, 29, 30, 35, and 36. Treatment continues in the absence of unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ovarian, peritoneal, or fallopian tube carcinoma\n* Radiographic, clinical, or pathologic evidence of relapse\n* Recurrent or persistent disease after chemotherapy (may be enrolled at first or subsequent relapse)\n\n * Received prior taxane OR platinum agent\n* Performance status - GOG 0-1\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* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT/SGPT no greater than 2.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n* Creatinine no greater than 1.5 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No grade 2 or greater neuropathy (sensory or motor)\n* No septicemia\n* No severe infection\n* No circumstance that would preclude study completion\n* No prior radiotherapy to the abdomen or pelvis\n* Patients with ureteral obstruction must undergo stent or nephrostomy tube replacement prior to study entry'}, 'identificationModule': {'nctId': 'NCT00066456', 'briefTitle': 'Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': 'A Phase I Study Using Low Dose Abdominal Radiotherapy as A Docetaxel Chemosensitizer for Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer', 'orgStudyIdInfo': {'id': 'GOG-9915'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00618', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000316238'}, {'id': 'GOG-9915'}, {'id': 'GOG-9915', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'GOG-9915', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA027469', 'link': 'https://reporter.nih.gov/quickSearch/U10CA027469', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (chemosensitization, radiation, docetaxel)', 'description': 'Patients receive docetaxel IV over 30 minutes once daily on days 1, 8, 15, 22, 29, and 35. Within 3 hours after beginning docetaxel, patients also receive low-dose abdominal radiotherapy twice daily (at least 4 hours apart) on days 1, 2, 8, 9, 15, 16, 22, 24, 29, 30, 35, and 36. Treatment continues in the absence of unacceptable toxicity.', 'interventionNames': ['Radiation: 3-Dimensional Conformal Radiation Therapy', 'Drug: Chemosensitization/Potentiation Therapy', 'Drug: Docetaxel']}], 'interventions': [{'name': '3-Dimensional Conformal Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['3-dimensional radiation therapy', '3D CONFORMAL RADIATION THERAPY', '3D CRT', '3D-CRT', 'Conformal Therapy', 'Radiation Conformal Therapy'], 'armGroupLabels': ['Treatment (chemosensitization, radiation, docetaxel)']}, {'name': 'Chemosensitization/Potentiation Therapy', 'type': 'DRUG', 'armGroupLabels': ['Treatment (chemosensitization, radiation, docetaxel)']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Docecad', 'RP56976', 'Taxotere', 'Taxotere Injection Concentrate'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (chemosensitization, radiation, docetaxel)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University/Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa/Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky/Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Lake University Ireland Cancer Center', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Cancer Care Associates-Midtown', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Paula Fracasso', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynecologic Oncology Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}