Colorectal Cancer
Conditions
Brief summary
This study determine the maximal tolerate dose
Detailed description
This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin
Interventions
DRUGOxaliplatin
Dose levels of Oxaliplatin: 4 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 Table 1: Dose levels Dose 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 \* Start level
DRUGLV5FU or Folfiri
Association of chemotherapy by LV5FU or Folfiri according pratician choice
DRUGOxycodone
Oxycodone
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged over 18 years old 2. Histologically confirmed diagnosis of colorectal or appendix cancer 3. 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 4. Peritoneal Carcinomatosis Index \> 17 5. Previous adjuvant chemotherapy is allowed 6. One or several lines of chemotherapy are allowed 7. 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 8. Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN 9. Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥ LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN 10. ECOG (Eastern Cooperative Oncology group) \< 1 11. Life expectancy higher than 8 weeks 12. Negative pregnancy test in women of childbearing potential 13. Use of an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment 14. Patients affiliated to a French Social Security System 15. Signed informed consent (IC) obtained before any study specific procedures
Exclusion criteria
1. Serum uracile ≥ 16 ng/ml 2. Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes) 3. Patients with anesthetic or medical contraindications to surgery 4. Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF 5. Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months. 6. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion 7. 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) 8. Pregnant or breastfeeding women 9. Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections 10. Participation in another clinical trial within 30 days prior to study entry 11. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study 12. ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | through study completion, an average of 3 year | To determine: \- Maximum tolerated dose (MTD), |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) | through study completion, an average of 3 year | To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue |
Countries
France
Outcome results
None listed