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Trial Title:
Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab
NCT ID:
NCT06003998
Condition:
Colorectal Cancer
Peritoneal Metastases
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Bevacizumab
Oxaliplatin
Irinotecan
Conditions: Keywords:
Peritoneal metastases
colorectal cancer
Intraperitoneal
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
2 weekly IP irinotecan (max 12 cycles), dose 75 mg flat dose
Arm group label:
Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab
Other name:
Intraperitoneal irinotecan
Intervention type:
Drug
Intervention name:
FOLFOX regimen
Description:
FOLFOX-4 regimens consist of 85 mg/m2 oxaliplatin plus 200 mg/m2 LV and 5-FU 400 mg/m2
bolus on day 1 followed by 1600 mg/m2 5-FU as a 46-h infusion
Arm group label:
Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab
Other name:
5-FU + oxaliplatin
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab according to standard of care
Arm group label:
Intraperitoneal irinotecan 75 mg + mFOLFOX-4 and bevacizumab
Other name:
Avastin
Summary:
The rationale of the current study is that the addition of intraperitoneal irinotecan (75
mg) to palliative systemic therapy is feasible and safe, and might result in an increased
overall and progression free survival in patients with unresectable colorectal peritoneal
metastases. The primary objectives are to explore the overall survival for the addition
of intraperitoneal irinotecan (75 mg) to palliative systemic therapy in patients with
unresectable colorectal peritoneal metastases. Secondary objectives are to assess the
progression-free survival, toxicity profile, patient reported outcomes, costs, tumor
response during trial treatment, and the systemic and intraperitoneal pharmacokinetics of
irinotecan and SN-38. This is a single-arm, open-label, phase II study and patients will
receive intraperitoneal irinotecan (75 mg) in combination with modified FOLFOX4 +
bevacizumab.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed colorectal cancer;
- Radiologically and clinically or pathologically confirmed unresectable colorectal
peritoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectable
disease due to anatomical location);
- WHO performance score of 0-1 with a life expectancy of >3 months;
- Aged 18 years or older;
- Written informed consent;
Exclusion Criteria:
- Presence of extensive systemic metastases that are deemed to be the dominant factor
determining prognosis in terms of life expectancy and performance status [e.g. no
imminent threat of impaired organ functioning due to the presence of systemic
metastases]);
- Prior cytoreductive surgery;
- Prior palliative systemic therapy for colorectal cancer;
- Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6
months;
- Homozygous UGT1A1*28 genotype;
- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
- Microsatellite instable (MSI) primary tumor
- Any contra-indication for the planned chemotherapy (e.g. active infection, serious
concomitant disease, severe allergy), as determined by the medical oncologist;
- Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an absolute
neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L, serum creatinine
of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin > 2x ULN and liver
transaminases of >5 x ULN.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Catharina Hospital
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Teun van den Heuvel, MD
Phone:
0031 40 239 6351
Email:
teun.vd.heuvel@catharinaziekenhuis.nl
Facility:
Name:
Erasmus Medical Centre
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Niels Guchelaar
Phone:
0031 10 703 9640
Email:
n.guchelaar@erasmusmc.nl
Start date:
December 27, 2022
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Catharina Ziekenhuis Eindhoven
Agency class:
Other
Source:
Catharina Ziekenhuis Eindhoven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06003998
