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COMPLETEDPHASE1

Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin

NCT03253133•Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

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
+2 more criteria

Locations (1)

Institut réginal du Cancer de Montpellier

Montpellier, France

Key Dates

Start Date

May 10, 2016

Primary Completion Date

October 28, 2020

Completion Date

April 24, 2023

Last Updated

May 3, 2023

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

Oxaliplatin

DRUG

LV5FU or Folfiri

DRUG

Oxycodone

DRUG

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Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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RECRUITINGPHASE1

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

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Metastatic Colorectal AdenocarcinomaStage III Colorectal Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease