Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03253133
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2016-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-02', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2017-08-16', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'To determine:\n\n\\- Maximum tolerated dose (MTD),'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve (AUC)', 'timeFrame': 'through study completion, an average of 3 year', 'description': 'To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study determine the maximal tolerate dose', 'detailedDescription': 'This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged over 18 years old\n2. Histologically confirmed diagnosis of colorectal or appendix cancer\n3. Peritoneal carcinomatosis of colorectal origin, presumed unresecable or non-optimally resecable, assessed by imaging (CT scan (Computed Tomography Scanner) and MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery\n4. Peritoneal Carcinomatosis Index \\> 17\n5. Previous adjuvant chemotherapy is allowed\n6. One or several lines of chemotherapy are allowed\n7. Hemoglobin ≥ 10 g/dL (red blood transfusion is allowed if needed), neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3 and white blood cells \\> 3000 /mm3\n8. Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN\n9. Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥ LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN\n10. ECOG (Eastern Cooperative Oncology group) \\< 1\n11. Life expectancy higher than 8 weeks\n12. Negative pregnancy test in women of childbearing potential\n13. Use of an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment\n14. Patients affiliated to a French Social Security System\n15. Signed informed consent (IC) obtained before any study specific procedures\n\nExclusion Criteria:\n\n1. Serum uracile ≥ 16 ng/ml\n2. Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes)\n3. Patients with anesthetic or medical contraindications to surgery\n4. Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF\n5. Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months.\n6. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion\n7. History or presence of other cancer within the past 5 years (except adequately treated in situ carcinoma of the cervix and non-melanoma skin cancer)\n8. Pregnant or breastfeeding women\n9. Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections\n10. Participation in another clinical trial within 30 days prior to study entry\n11. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study\n12. ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women"}, 'identificationModule': {'nctId': 'NCT03253133', 'acronym': 'NIPOX', 'briefTitle': 'Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC', 'organization': {'class': 'OTHER', 'fullName': "Institut du Cancer de Montpellier - Val d'Aurelle"}, 'officialTitle': 'Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin', 'orgStudyIdInfo': {'id': 'ICM-URC2015/34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxaliplatin', 'description': 'IP neoadjuvant chemotherapy protocol:\n\nOxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour.\n\nIntravenous chemotherapy protocol:\n\nAssociated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed.', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: LV5FU or Folfiri', 'Drug: Oxycodone']}], 'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Dose levels of Oxaliplatin:\n\n4 dose levels of Oxaliplatin (85, 100, 130 and 160 mg/m²) are planned. 1 dose level is planned (-1 : 70 mg/m²) if DLT is reached at level 1\n\nTable 1: Dose levels\n\nDose Level Dose (mg/m²) Number of patients DL -1 70 mg 3-6 DL 1 \\* 85 mg 3-6 DL 2 100 mg 3-6 DL 3 130 mg 3-6 DL 4 160 mg 3-6\n\n\\* Start level', 'armGroupLabels': ['Oxaliplatin']}, {'name': 'LV5FU or Folfiri', 'type': 'DRUG', 'description': 'Association of chemotherapy by LV5FU or Folfiri according pratician choice', 'armGroupLabels': ['Oxaliplatin']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Oxycodone', 'armGroupLabels': ['Oxaliplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut réginal du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Olivia Sgarbura', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut régional du Cancer de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut du Cancer de Montpellier - Val d'Aurelle", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}