Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-26 @ 7:58 PM
Study NCT ID:
NCT00005832
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2000-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C402769', 'term': 'tipifarnib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-16', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2004-04-23', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Time to treatment failure', 'timeFrame': 'Once every 8 weeks until progression'}, {'measure': 'Evaluate the frequency and severity of toxicities', 'timeFrame': 'Weekly for 8 weeks and then once every 4 weeks'}, {'measure': 'Assess confirmed response (complete & partial) in patients with measurable advanced adenocarcinoma of the pancreas', 'timeFrame': 'Once every 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage II pancreatic cancer', 'stage III pancreatic cancer', 'duct cell adenocarcinoma of the pancreas', 'adenocarcinoma of the pancreas', 'stage IV pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'referencesModule': {'references': [{'pmid': '16133800', 'type': 'RESULT', 'citation': 'Macdonald JS, McCoy S, Whitehead RP, Iqbal S, Wade JL 3rd, Giguere JK, Abbruzzese JL. A phase II study of farnesyl transferase inhibitor R115777 in pancreatic cancer: a Southwest oncology group (SWOG 9924) study. Invest New Drugs. 2005 Oct;23(5):485-7. doi: 10.1007/s10637-005-2908-y.'}, {'type': 'RESULT', 'citation': 'Macdonald JS, Chansky K, Whitehead R, et al.: A phase II study of farnesyl transferase inhibitor R115777 in pancreatic cancer. A Southwest Oncology Group (SWOG) study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-548, 2002.'}]}, '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 R115777 in treating patients who have locally advanced or metastatic pancreatic cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine the six month survival rate in patients with advanced adenocarcinoma of the pancreas treated with R115777. II. Determine the time to treatment failure and confirmed response in this patient population treated with this regimen. III. Evaluate the frequency and severity of toxicities associated with this treatment regimen in these patients.\n\nOUTLINE: Patients receive oral R115777 twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Ductal adenocarcinoma Mucinous noncystic carcinoma Signet ring cell carcinoma Adenosquamous carcinoma Undifferentiated (anaplastic) carcinoma Mixed ductal endocrine carcinoma Well differentiated adenocarcinoma Moderately well or poorly differentiated adenocarcinoma Undifferentiated ductal carcinoma No papillary cystic carcinomas, sarcomas, or tumors arising from the endocrine pancreas Pathological confirmation of a metastatic site allowed Clinical documentation of pancreatic involvement and no evidence of another primary allowed Locally advanced or distant metastatic disease surgically incurable No known brain metastases\n\nPATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: Ability to swallow and/or receive enteral medications via gastrostomy feeding tube No intractable nausea or vomiting No other prior malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission Not pregnant or nursing Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy Chemotherapy: No prior chemotherapy No prior adjuvant or neoadjuvant chemoradiotherapy, including for advanced pancreatic cancer No other concurrent chemotherapy Endocrine therapy: No prior or concurrent hormonal therapy Radiotherapy: See Chemotherapy No prior radiotherapy, except for palliation to metastatic sites No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery for pancreatic cancer and recovered Prior partial resections of the stomach and duodenum for pancreatic cancer allowed No prior major resection of the small intestine Prior pancreaticduodenectomy for pancreatic cancer allowed Other: No concurrent proton pump inhibitors (e.g., omeprazole) Concurrent antacids or H2 blockers allowed No other concurrent therapy for pancreatic cancer'}, 'identificationModule': {'nctId': 'NCT00005832', 'briefTitle': 'S9924 R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'SWOG Cancer Research Network'}, 'officialTitle': 'A Phase II Trial of R115777 (NSC #702818) in Patients With Advanced Pancreas Cancer', 'orgStudyIdInfo': {'id': 'CDR0000067846'}, 'secondaryIdInfos': [{'id': 'S9924', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'U10CA032102', 'link': 'https://reporter.nih.gov/quickSearch/U10CA032102', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R115777', 'description': '300mg/dose BID, PO, Days 1-21, q 28days', 'interventionNames': ['Drug: R115777']}], 'interventions': [{'name': 'R115777', 'type': 'DRUG', 'otherNames': ['tipifarnib'], 'description': '300mg/dose BID, PO, Days 1-21, q 28days', 'armGroupLabels': ['R115777']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033-0800', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94553', 'city': 'Martinez', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Outpatient Clinic - Martinez', 'geoPoint': {'lat': 38.01937, 'lon': -122.13413}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '62526', 'city': 'Decatur', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Central Illinois', 'geoPoint': {'lat': 39.84031, 'lon': -88.9548}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67218', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '59101', 'city': 'Billings', 'state': 'Montana', 'country': 'United States', 'facility': 'CCOP - Montana Cancer Consortium', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '43206', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Greenville', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '77555-0209', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Virginia Mason Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405-0986', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Northwest', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'John S. MacDonald, MD', 'role': 'STUDY_CHAIR', 'affiliation': "St. Vincent's Comprehensive Cancer Center - Manhattan"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}