Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT00080834
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2004-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479543', 'term': 'tesetaxel'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-15', 'studyFirstSubmitDate': '2004-04-07', 'studyFirstSubmitQcDate': '2004-04-07', 'lastUpdatePostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the colon', 'adenocarcinoma of the rectum', 'recurrent colon cancer', 'recurrent rectal cancer', 'stage III colon cancer', 'stage IV colon cancer', 'stage III rectal cancer', 'stage IV rectal cancer'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Rhee JM, Lee FC, Saif MW, et al.: Phase II trial of DJ-927 as a second-line treatment for colorectal cancer demonstrates objective responses. [Abstract] J Clin Oncol 23 (Suppl 16): A-3654, 284s, 2005.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as DJ-927, work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: This phase II trial is studying how well DJ-927 works as second-line therapy in treating patients with progressive locally advanced or metastatic colorectal adenocarcinoma (cancer).', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the objective tumor response rate in patients with progressive locally advanced or metastatic adenocarcinoma of the colon or rectum treated with DJ-927 as second-line treatment.\n\nSecondary\n\n* Determine the duration of response in patients treated with this drug.\n* Determine the time to tumor progression in patients treated with this drug.\n* Determine the median survival time in patients treated with this drug.\n* Determine the quantitative and qualitative toxic effects of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n\nOUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior first-line treatment regimen (irinotecan-containing vs oxaliplatin-containing).\n\nPatients receive oral DJ-927\\* on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nNOTE: \\*Patients receive 1 of 2 selected doses to confirm the previously established maximum tolerated dose\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 56-62 patients (28-31 per stratum) will be accrued for this study within 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the colon or rectum\n\n * Progressive locally advanced or metastatic disease\n* Received 1 prior irinotecan- or oxaliplatin-containing regimen\n* At least 1 measurable lesion\n\n * Target lesion must be outside field of prior radiotherapy\n* No symptomatic brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 3 months\n\nHematopoietic\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* ALT and AST ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)\n* Bilirubin ≤ 1.5 times ULN\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN\n\nGastrointestinal\n\n* No difficulty with swallowing\n* No malabsorption\n* No diarrhea (excess of 2-3 stools/day above normal frequency) within the past month\n* No history of chronic diarrhea\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No concurrent serious infection\n* No other concurrent severe or uncontrolled underlying medical condition that would preclude study participation\n* No neuropathy ≥ grade 2\n* No history of any severe or life-threatening hypersensitivity reaction\n* No psychiatric disorder that would preclude study compliance\n* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No concurrent biologic therapy\n\nChemotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior myelosuppressive chemotherapy and recovered\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy and recovered\n* No concurrent radiotherapy\n\n * Localized radiotherapy to non-indicator lesions for pain relief allowed provided other methods of pain control are ineffective\n\nSurgery\n\n* At least 4 weeks since prior major surgery and recovered\n* No prior major surgery in the stomach or small intestine\n\nOther\n\n* More than 28 days since prior investigational agents (including analgesics and/or antiemetics)\n* No other concurrent anticancer therapy\n* No other concurrent cytotoxic therapy\n* No concurrent grapefruit products'}, 'identificationModule': {'nctId': 'NCT00080834', 'briefTitle': 'DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase II Study Of Oral DJ-927 Administered As A Single Dose Every Three Weeks To Patients With Advanced Or Metastatic Adenocarcinoma Of The Colon Or Rectum', 'orgStudyIdInfo': {'id': 'CDR0000356034'}, 'secondaryIdInfos': [{'id': 'DAIICHI-927A-PRT004'}, {'id': 'MDA-2003-0749'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DJ-927', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131-5636', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Research and Treatment Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Peter Cheverton, MD, ChB, MMED, RadT', 'role': 'STUDY_CHAIR', 'affiliation': 'Daiichi Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}