Metastatic colorectal cancer MedDRA version: 14.1 Level: LLT Classification code 10010036 Term: Colorectal carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: LEDERFOLIN*INFUS 1FL 100MG
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: CALCIUM FOLINATE
CAS Number: 1492-18-8
Concentration unit: mg/m2 milligram(s)/square m
Sponsors
ARCO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically proven diagnosis of colorectal cancer. •Not resectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease. •At least one measurable lesion according to RECIST criteria. •Male or female of 18-75 years of age. •ECOG PS 9 g/dl. •Total bilirubin 1.5 time the upper-normal limits (UNL) of the institutional normal values and ASAT (SGOT) and/or ALAT (SGPT) 2.5 x UNL, or 5 x UNL in case of liver metastases, alkaline phosphatase 2.5 x UNL, 5 x UNL in case of liver metastases. •Creatinine clearance >50 mL/min or serum creatinine 1.5 x UNL. •Urine dipstick of proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range 62
Exclusion criteria
Exclusion criteria: •Radiotherapy to any site within 4 weeks before the study. •Previous treatment with bevacizumab •Untreated brain metastases or spinal cord compression or primary brain tumours. •History or evidence upon physical examination of CNS disease unless adequately treated. ?Symptomatic peripheral neuropathy > 2 grade NCIC-CTG criteria; •Serious, non-healing wound, ulcer, or bone fracture. •Evidence of bleeding diathesis or coagulopathy. •Uncontrolled hypertension. •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (=6 months), myocardial infarction (=6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication. •Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes. •Chronic, daily treatment with high-dose aspirin (>325 mg/day). •Treatment with any investigational drug within 30 days prior to enrolment. •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ. •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study. •Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication. •Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study (barriere contraceptive measure or oral contraception).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To preliminary evaluate the progression-free survival (PFS) of maintenance treatment with bevacizumab or with bevacizumab plus metronomic chemotherapy with capecitabine and cyclophosphamide after 4 months of first-line induction FOLFOXIRI plus bevacizumab.;Secondary Objective: •Overall response rate (ORR), •Resection rate, •Duration of response, •Time to strategy failure (TSF), •Time to 2nd PD, •Overall survival (OS), •Safety profile, •Evaluation of potential surrogate markers predictive of bevacizumab and metronomic chemotherapy activity, including pharmacodynamic and pharmacogenetic parameters, •Correlation of pharmacokinetic data of cytotoxic agents (capecitabine and cyclophosphamide) administered as metronomic chemotherapy with activity and efficacy.;Primary end point(s): •Progression-free survival (PFS) will be measured from the day of randomization until the first observation of disease progression or death due to any cause.;Timepoint(s) of evaluation of this end point: Every 2 months during the tumor evaluation (RECIST criteria v1.1) using the CT scan technique | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Overall response rate (ORR), •Resection rate, •Duration of response, •Time to strategy failure (TSF), •Time to 2nd PD, •Overall survival (OS), •Safety profile, •Evaluation of potential surrogate markers predictive of bevacizumab and metronomic chemotherapy activity, including pharmacodynamic and pharmacogenetic parameters, •Correlation of pharmacokinetic data of cytotoxic agents (capecitabine and cyclophosphamide) administered as metronomic chemotherapy with activity and efficacy.;Timepoint(s) of evaluation of this end point: 4 years/end of the study | — |
Countries
Italy
Contacts
Public ContactUfficio Sperimentazioni
U.O. Oncologia Medica Azienda Ospedaliero-Universitaria Pisana
Outcome results
None listed