Advanced colorectal carcinoma MedDRA version: 14.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient must have histological or cytological confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies, not susceptible of radical surgery of metastases. 2.Patients without progressive disease after six months of the standard first line chemotherapy regimen for CRC (fluoropirimidina (5FU o capecitabina) + oxaliplatino (FOLFOX, FUOX, XELOX) o irinotecán (FOLFIRI, FUIRI, XELIRI)) + bevacizumab o cetuximab. 3.Patient must have at least one measurable lesion as defined by modified RECIST criteria. 4.Male or female, age ?18 years. 5.ECOG performance status of 0 or 1 and life expectancy of ?12 weeks. 6.Adequate organ function as defined by the following criteria: ? absolute neutrophil count (ANC) ?1500 cells/mm3; ? platelets ?100,000 cells/mm3. ? Hemoglobin ?9.0 g/dL. ? AST and ALT ?2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT ?5.0 x ULN; ? Total bilirubin ?1.5 x ULN; ? Serum creatinine ?1.5 x ULN or calculated creatinine clearance ?50 mL/min; ? Urinary protein =65 years) yes F.1.3.1 Number of subjects for this age range 84
Exclusion criteria
Exclusion criteria: 1. Gastrointestinal abnormalities including: ? inability to take oral medication; ? requirement for intravenous alimentation; ? prior surgical procedures affecting absorption including total gastric resection; ? treatment for active peptic ulcer disease in the past 6 months; ? active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy; ? malabsorption syndromes. ? History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to start, unless affected area has been removed surgically 2. Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine). 3. Current use or anticipated need for treatment with drugs that are known CYP3A4 (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John?s wort). 4. History of haemorrhage within the past 6 months, including gross hemoptysis or hematuria. 5. Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed. 6. Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis. 7. A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment. 8. Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism. 9. Ongoing cardiac dysrhythmias of NCI CTCAE grade 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females. 10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 11. History of a malignancy (other than colorectal cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years. 12. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 13. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. 14. Current, recent (within 4 weeks of the study treatment administration), or planned participation in an experimental therapeutic drug study other than this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the maintenance therapy with AG-013736 is able to improve the PFS in patients with low risk of recurrence and advanced CRC without progressive disease after 6 months of treatment with an standard front line chemotherapy;Secondary Objective: To compare the ORR, duration of response (DR) and Duration of Disease Control (DDC) of maintenance therapy with AG-013736 versus placebo To evaluate OS To evaluate the safety and tolerability (Toxicity during each treatment cycle was assessed according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 4.0;Primary end point(s): To evaluate if the maintenance therapy with AG-013736 is able to improve the PFS in patients with low risk of recurrence and advanced CRC without progressive disease after 6 months of treatment with an standard front line chemotherapy;Timepoint(s) of evaluation of this end point: Date of first observed Progression Dissease or the date of death due to any cause (if occurring before progression) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? To compare the ORR, duration of response (DR) and Duration of Disease Control (DDC) of maintenance therapy with AG-013736 versus placebo To evaluate OS To evaluate the safety and tolerability (Toxicity during each treatment cycle was assessed according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 4.0;Timepoint(s) of evaluation of this end point: Date of first observed Progression Dissease or the date of death due to any cause | — |
Countries
Spain
Contacts
Public ContactYolanda Martín
TFS
Outcome results
None listed