metastatic colorectal cancer MedDRA version: 14.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: oxaliplatino
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentr
Sponsors
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient's Infomed consent in written. 2.Age between 18 and 70 years old. 3.ECOG 0-1. 4.Life expectancy of at least 3 months. 5.Histological confirmation of adenocarcinoma of the colon or rectum. 6.To be included in the study patients should present > or equal 3 CTC in peripheral blood. 7.Measurable metastatic stage IV disease with at least 1 measurable metastatic lesion following RECIST criteria v 1.1 (non suitable for radical surgery at the inclusion time). 8.Prior radiotherapy is allowed but must be completed at least 4 weeks before randomization (if applicable). 9.Adequate bone marrow, liver and renal function. 10.Women of childbearing potential must have a negative serum or urine pregnancy test. Postmenopausal women must have been amenorrheic for at least 12 months.Both men and women participating in this study must use adequate contraception (eg. Abstinence, intrauterine device, oral contraceptive or double-barrier method or surgically sterile), beginning at the signing ICF and for at least 6 months after the last study drug administration the first occurs. 11.Subject must have the ability, in the opinion of the investigator, to comply with all the study procedures and follow-up examinations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1.Previous chemotherapy for metastatic disease, except the cases listed in the protocol. 2.Prior treatment with Bevacizumab, or EGFR inhibitors 3.Any anticancer treatment (chemotherapy, hormonal treatment, radiation treatment, surgery , immunotherapy, biologic therapy or tumour embolization) within 4 weeks before randomization. 4.Use of any investigational drug within 4 weeks before start the treatment 5.Clinical or radiographic evidence of brain metastasis. 6.Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg on repeated measurement) despite optimal medical management. 7.Previous history of hypertensive encephalopathy or hypertensive crises. 8.Current or history of peripheral neuropathy > or equal to 1 NCI-CTCAE. 9.Patients classified as fragile according to crteria listed in the protocol. 10.Significant vascular disease (e.g. AVC, myocardial infarction, within 6 months before randomization). Unstable angina congestive heart failure- New York Heart Association (NYHA) ? class II, arrhythmia that requires treatment within 3 months before randomization. 11.Significant vascular disease (e.g. aortic aneurism requiring surgical intervention, pulmonary embolic, peripheral arterial thrombosis) within 6 months before randomization. 12.Previous history of significant haemorrhage /severe, within 1 month before randomization. 13.Major surgery, open surgical biopsy or significant traumatic injury within 4 weeks before randomization. 14.Large bore needle biopsy of a major organ within 14 days before randomization. Placement of central venous access port > or equal to 7 days before randomization is permitted 15.Evidence or history of bleeding diathesis or coagulopathy. 16.INR >1.5 within 14 days prior to starting study treatment. aPTT > 1.5 x ULN within 14 days prior to starting study treatment. EXEMPTION: patients on full anticoagulation due to VTE must have an in-range INR[usually between 2-3]. Any anticoagulation therapy must be at stable dosing prior to enrolment. 17.History of previous abdominal fistula or gastrointestinal perforation within 6 months before randomization. 18.Serious non-healing wound, ulcer or bone fracture. 19.Acute or sub-acute of intestinal occlusion or history of intestinal inflammatory disease. 20.History of uncontrolled convulsive crises. 21.History of pulmonary fibrosis, acute lung disease or interstitial pneumonia. 22.Chronic, actual o recent use (10 days prior first drug administration) of acetilsalicilic acic (aspirin) > 325 mg/day or clopidogrel (75mg/day) or other treatments that can cause gastrointestinal ulcer (low-dose aspirin is permitted or equal to 2+ (dipstick). If > or equalo 2 g proteinuria is detected with dipstick, a 24-hour period urine test will be performed and the result should be or equal to Grade 2 (NCI-CTCAE). 26.Any previous or concurrent cancer different to colorectal carcinoma within 5 years before to start the treatment. Subjects with successfully-treated, non-invasive cancers, including cervical cancer in situ, basal cell carcinoma will be allowed to participate in the clinical trial. Or those cancer tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Progression free survival (PFS) efficacy compared between FOLFOX + Bevacizumab vs FOLFOXIRI + Bevacizumab, in mCRC first line treated patients with 3 or more Circulating tumor cells (CTC).;Secondary Objective: Secondary: -Overall survival (OS) in both tratment groups. - Objective Response rate (ORR) in both treatment groups, according to RECIST crietria v1.1. -Tumoral complete surgery rate (R0) in both tratment groups. -CTC count in blood and correlate to PFS, OS, RR in both tratment groups. - Status KRAS, BRAF and PI3K (native or mutant) and correlate to PFS, OS, RR in both tratment gropups. - Safety profile in both tratment groups. Exploratory: - Exploratory analysis on biomarkers on the cellular and tumoral reproduction and/or mode of action on the study drugs.;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: Date in which progression or death for any cause is documented (what happens before) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Overal survival -Objective Response rate (ORR) -Tumoral surgery rate (R0) -Adverse events. -Baseline CTC counts -KRAS, BRAF, PI3K status.;Timepoint(s) of evaluation of this end point: -Baseline, Death or end of study (see protocol) | — |
Countries
Spain
Contacts
Public ContactInmaculada Ruiz de Mena
Grupo de Tratamiento de los Tumores Digestivos (TTD)
Outcome results
None listed