Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-28 @ 9:54 PM
Study NCT ID:
NCT00016250
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2001-05-06', 'studyFirstSubmitQcDate': '2003-10-14', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV colon cancer', 'stage IV rectal cancer', 'recurrent colon cancer', 'recurrent rectal cancer', 'adenocarcinoma of the colon', 'adenocarcinoma of the rectum'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of Ro 31-7453 in treating patients who have recurrent or refractory metastatic colorectal cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare the objective disease rate of patients with recurrent or refractory metastatic colorectal cancer treated with two dose schedules of Ro 31-7453.\n* Compare the safety and tolerability of these regimens in these patients.\n* Compare the response duration in patients treated with these regimens.\n* Compare the time to progression and time to treatment failure in patients treated with these regimens.\n* Determine the pharmacokinetic profiles of Ro 31-7453 and its major metabolites in these patients.\n* Compare the overall survival of patients treated with these regimens.\n\nOUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive oral Ro 31-7453 twice daily on days 1-4. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive oral Ro 31-7453 twice daily on days 1-14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed at 28 days and then every 3 months.\n\nPROJECTED ACCRUAL: Approximately 160 patients (49 per treatment arm plus 61 additional patients in the arm determined to be most effective) will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed metastatic adenocarcinoma of the colon or rectum\n* Bidimensionally measurable disease\n\n * At least 2.0 x 2.0 cm\n* Failed prior fluoropyrimidine and irinotecan chemotherapy in adjuvant or metastatic setting\n\n * Must have had disease progression while receiving chemotherapy OR\n * If received fluorouracil with or without irinotecan in adjuvant setting, must also have failed therapy with these agents in metastatic setting (unless manifesting metastatic disease during adjuvant therapy)\n* No known CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* Karnofsky 70-100%\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Hemoglobin at least 9 g/dL\n* Absolute neutrophil count at least 1,500/mm\\^3\n* WBC at least 3,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* AST/ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)\n* Alkaline phosphatase no greater than 2.5 ULN (5 times ULN if bone or liver metastases present)\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No New York Heart Association class III or IV congestive heart failure\n* No myocardial infarction within the past 6 months\n\nGastrointestinal:\n\n* No bowel obstruction\n* No active uncontrolled malabsorption syndrome\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active infection\n* No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer\n* No other active cancers, including stable disease on adjuvant therapy\n* No other medical condition that would preclude study\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* See Chemotherapy\n* At least 2 weeks since prior biologic therapy and recovered\n\nChemotherapy:\n\n* See Disease Characteristics\n* No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease\n* Monoclonal antibody (MOAB) therapy and antiangiogenic agents not included as prior cytotoxic chemotherapy\n* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy and recovered\n\nSurgery:\n\n* No prior total gastrectomy\n\nOther:\n\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00016250', 'briefTitle': 'Ro 31-7453 in Treating Patients With Recurrent or Refractory Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': "A Randomized Phase II Study of Two Shcedules of Ro 31-7453 in Patients With Metastatic (Dukes' D) Colorectal Carcinoma (CRC) Who Have Failed Both Fluoropyrimidine and Irinotecan Chemotherapy", 'orgStudyIdInfo': {'id': '00-139'}, 'secondaryIdInfos': [{'id': 'CDR0000068613', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'ROCHE-16113'}, {'id': 'ROCHE-RO31-7453'}, {'id': 'NCI-G01-1945'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MKC-1', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sunil Sharma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}