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This study determine the maximal tolerate dose
This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxaliplatin | Experimental | IP neoadjuvant chemotherapy protocol: Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour. Intravenous chemotherapy protocol: Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | To determine: - Maximum tolerated dose (MTD), | through study completion, an average of 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) | To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue | through study completion, an average of 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivia Sgarbura | Institut régional du Cancer de Montpellier | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut réginal du Cancer de Montpellier | Montpellier | 34298 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
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|
| LV5FU or Folfiri | Drug | Association of chemotherapy by LV5FU or Folfiri according pratician choice |
|
| Oxycodone | Drug | Oxycodone |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009019 |
| Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |