Status:
TERMINATED
Oxaliplatin in PIPAC for Nonresectable Peritoneal Metastases of Digestive Cancers
Lead Sponsor:
Institut Cancerologie de l'Ouest
Conditions:
Digestive Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Current curative treatment of digestive peritoneal carcinomatosis consists of complete cytoreduction surgery associated with intraperitoneal chemotherapy. This treatment has important limits: a high m...
Detailed Description
The objective of this study is to determine the maximum tolerated dose (mtd) of oxaliplatin to be used during PIPAC. Study design is a phase I/II, multicentre, non-comparative, non-randomised dose es...
Eligibility Criteria
Inclusion
- 1\. Patient age ≥ 18 years 2. Histological or cytological diagnosis or suspicion of peritoneal carcinosis of colorectal, gastric or bowel origin 3. Having previously received at least 3 months of systemic chemotherapy for metastatic disease (type of chemotherapy left to the discretion of each investigator). Patients who received bevacizumab (Avastin®) can be included if and only if the time between the last treatment administered and the first PIPAC received is at least 4 weeks 4. ECOG performance index \< or = 2 5. Life expectancy\> 3 months 6. Peripheral neuropathy grade ≤ 1 7. Hematological function: Hemoglobin ≥ 9 g / dL, leukocytes ≥ 4000 / mm3, PNN ≥ 1500 / mm3, platelets ≥ 100 000 / mm3 8. Creatinine clearance\> 50 mL / min (cockcroft and Gault formula) 9. Hepatic function: Total bilirubin ≤ 1.5 x ULN, ASAT and ALAT ≤ 3 x ULN, Alkaline phosphatases ≤ 3 x ULN 10 . Patients with no known or partial deficiency of Dihydropyrimidine dehydrogenase (i.e. DPD) 11. Effective contraception for women of childbearing age 13. Informing the patient and obtaining free, informed and written consent signed by the patient and his / her investigator.
- 14\. Affiliated subject or beneficiary of the social security scheme.
Exclusion
- Patients who received bevacizumab (Avastin®) less than 4 weeks ago can not be included
- Extra-peritoneal metastases, except for less than 3 pulmonary nodules (each size \<5mm)
- Known hypersensitivity to Oxaliplatin
- Known complete dihydropyrimidine dehydrogenase (i.e. DPD) deficiency
- Peripheral neuropathy Grade \>1 due to or not with Oxaliplatin previously used
- Active or other serious underlying disease that may prevent the patient from receiving treatment
- Intracranial or intraocular hypertension (ongoing at the time of inclusion)
- Severe or Severe Heart Failure (ongoing at the time of inclusion)
- Complete intestinal obstruction (ongoing at the time of inclusion)
- Other concurrent cancer or history of cancer other than in situ cancer of treated cervix or basal cell carcinoma or squamous cell carcinoma
- Pregnant or nursing women
- Persons deprived of their liberty or under guardianship or unable to give their consent
- Inability to submit to medical follow-up of the trial for geographical, social or psychological reasons
- Long-term corticosteroids (duration\> 3 months), except for weaning for at least 3 months
Key Trial Info
Start Date :
May 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03294252
Start Date
May 24 2017
End Date
October 1 2021
Last Update
April 25 2022
Active Locations (3)
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1
Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
2
ICO René Gauducheau
Saint-Herblain, France, 44805
3
Hopital Begin
Saint-Mandé, France, 94163