Clinical trial NCT02219893: Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
Official title: Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Neoplasms
Keywords: Peritoneal Carcinomatosis
Peritoneal Metastasis
Colorectal Cancer
Cytoreductive surgery
HIPEC
Intraperitoneal treatment
Immunotoxin
MOC31PE
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is through a phase I/II clinical trial to assess the safety and toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for peritoneal metastases from colorectal cancer (CRC).

Detailed description: MOC31PE is an immunotoxin that has previously been evaluated in a phase I clinical study involving patients with advanced EpCAM positive carcinoma to assess the safety and tolerability profile and the pharmacokinetic behavior of the compound. In this study, the compound was administered intravenously and was well tolerated. MOC31PE will now be evaluated on the same parameters in a new phase I/II clinical trial, where the drug will be administered intraperitoneally to patients with peritoneal metastases from EpCAM positive colorectal carcinomas.

Eligibility criteria: Inclusion criteria:

* Histologically verified EpCAM positive colorectal cancer
* Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at the time of surgery
* At least 18 years of age
* Suspected isolated peritoneal carcinomatosis upon radiologic work-up
* Complete cytoreduction at surgery and mitomycin C given as standard HIPEC procedure
* Peritoneal Cancer Index (PCI) ≤ 20
* Laboratory values at inclusion:

  * Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
  * Platelets \> 100 x 10\^9/L
  * Hb \> 9g/dL
  * Creatinine ≤ 2x upper limit of normal
  * Bilirubin \< 2.0x the upper limit of normal
  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2. 5x the upper limit of normal
  * Albumin levels \> 30 g/L
  * International normalised ratio (INR) \<1.3
* Signed informed consent and expected cooperation with respect to treatment and follow-up must be obtained and documented according to International Conference of Harmonisation- Good clinical Practice (ICH GCP), and national/local regulations.

Exclusion criteria:

* Other synchronous metastatic lesions. Patients may be included if they have had curative resection of metastatic CRC disease more than 2 years prior to inclusion and have no relapse at this location is detected.
* History of prior other malignant disease the last 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer.
* History of central nervous system (CNS)- or bone metastases
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
* History of any liver disease including Hepatitis B or C infection
* Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
* BMI \> 35
* Pregnant or breast-feeding patients
* Alcohol or drug abuse
* Use of drugs that can influence hepatic function (e.g. phenytoin or phenobarbital)
* Use of anticoagulants
* Any reason why, in the opinion of the investigator, the patient should not participate in the study protocol

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 5 years or until disease progression
Secondary outcomes:
measure: Cmax, Tmax
timeFrame: 8 weeks
measure: Neutralizing anti-immunotoxin antibody response
timeFrame: 8 weeks
measure: Biomarkers of disease recurrence
timeFrame: 5 years or until disease progression
measure: Overall survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital- The Norwegian Radium Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kjersti Flatmark, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Svein Dueland, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: