Colon Cancer
Conditions
Interventions
Trade Name: EVEROLIMUS
Product Name: EVEROLIMUS
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
Unidad integral de investigación en oncologia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed IC 2. Cytological o pathological diagnosis of colorectal adenocarcinome, methastasic or refractary at least at one previous chemotheraphy and without effective chirurgical treatment. 3. At least for weeks since the last treatment at the beginning of the study. 4. Tumoural tissue available for mutation analysis, if not, the patient must permit to undergo to a biopsy. 5. Tumoural mutations in Pl3KCA gene. The mutations will be determinate by Kathleen Murphy at the Pathology department, Johns Hopkins Hospital. 6. Patients with biopsiable disease or agree to undergo to two biopsies (skin and tumour). 7. Age = 18. 8. ECOG 0-2 (Karnofski = 60 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients whose have received radio or chemotheraphy ( 6 weeks if treatment with nitrosourees or mitomicine C) on the previous 4 weeks before starting the trial. Also if they are not recovered from the adverse effects produced by previous oncologycal treatments. 2. Patients whose have had previous medicaments with a m-tor against target. 3. Patients with another experimental treatment. 4. Patients with cerebral metastasis. The prognostic for these patients is actually bad and the neurological symptomatology associated can make more laborious to evaluate the adverse effects associated to RAD001 5. Allergic to any substance similar to RAD001 6. Patients having forbidden treatments points 5.4.3 and 5.4.4 from the protocol. 7. Not controlled intercurrent diseases as hypertension, infections, cardiac insufficiency, pectoris angina, cardiac arrhythmias or psychiatric psychosocial diseases. 8. Antecedents or evidence of hereditary hemorrhagic diathesis or coagulophaty with hemorrhagic risk. 9. Patients can not receive anticoagulant treatment. It is allowed to receive prophylactic treatments (for example warfarin at low doses ) in case of venous or arterial reservoirs and only if TTPa, INR and TP requirements are ok. 10. Incapacity to take oral treatments or previous chirurgical treatments that affect to absortion or make necessary i.v. nutrition or parenteral lipid nutrition. 11. Women in pregnancy or in laitance period. A negative pregnancy test is required (in serum or orine) 7 days before starting the trial in all premenopausal women . RDA001 effects on foetus are unknowns, so women on laitance period must interrupt it before starting the treatment. 12. Patients with immune deficiencies have a bigger risk of lethal infections when mielosuppressor treatment is given. Patients with HIV and a retroviral therapy will be excluded from this trial because of possible medicamentous interactions with RAD001 or another medicaments administrated on this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the response, time to progression and survival in patients with colorectal cancer and mutation in the Pl3KCA treated with RAD001. ;Secondary Objective: To fix the toxicity profile of this medicament in this kind of patients. To analyze the signalization pathways activated in this kind of patients. To fix the pharmadinamic effects of RAD001 on tumour biopsies and healthy tissue (skin) obtained from this kind of patients.;Primary end point(s): free disease progression survival global survival clinical response | — |
Countries
Spain
Outcome results
None listed