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Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC (NIPOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03253133
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary:
This study determine the maximal tolerate dose

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: Oxaliplatin Drug: LV5FU or Folfiri Drug: Oxycodone Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin
Study Start Date : February 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oxaliplatin

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.

Drug: Oxaliplatin

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

Drug: LV5FU or Folfiri
Association of chemotherapy by LV5FU or Folfiri according pratician choice

Drug: Oxycodone

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: through study completion, an average of 3 year ]

    To determine:

    - Maximum tolerated dose (MTD),

Secondary Outcome Measures :
  1. Area Under the Curve (AUC) [ Time Frame: through study completion, an average of 3 year ]
    To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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
  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. Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes)
  2. Patients with anesthetic or medical contraindications to surgery
  3. Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF
  4. Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months.
  5. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion
  6. 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)
  7. Pregnant or breastfeeding women
  8. Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections
  9. Participation in another clinical trial within 30 days prior to study entry
  10. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03253133

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Institut réginal du Cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: Olivia SGARBURA    0033467613102   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
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Study Chair: Olivia Sgarbura Institut régional du Cancer de Montpellier

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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle Identifier: NCT03253133     History of Changes
Other Study ID Numbers: ICM-URC2015/34
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Peritoneal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Antineoplastic Agents
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents