NCT02219893

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

August 8, 2014

Last Update Submit

May 24, 2017

Conditions

Colorectal Neoplasms

Keywords

Peritoneal CarcinomatosisPeritoneal MetastasisColorectal CancerCytoreductive surgeryHIPECIntraperitoneal treatmentImmunotoxinMOC31PE

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Follow-up: 5 years from administration of study drug, or until disease progression

    5 years or until disease progression

Secondary Outcomes (5)

  • Cmax, Tmax

    8 weeks

  • Neutralizing anti-immunotoxin antibody response

    8 weeks

  • Biomarkers of disease recurrence

    5 years or until disease progression

  • Overall survival

    5 years

  • Disease free survival

    5 years

Study Arms (1)

MOC31PE Immunotoxin

EXPERIMENTAL

Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.

Drug: MOC31PE Immunotoxin

Interventions

MOC31PE ImmunotoxinDRUG

Patients who meet inclusion criteria will be treated with a single intraperitoneal MOC31PE immunotoxin instillation for 6 hours on the first day after CRS and HIPEC

MOC31PE Immunotoxin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital- The Norwegian Radium Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPeritoneal Neoplasms

Interventions

MOC31PE immunotoxin

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAbdominal NeoplasmsPeritoneal Diseases

Study Officials

  • Kjersti Flatmark, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Svein Dueland, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant medical oncology

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 19, 2014

Study Start

August 1, 2014

Primary Completion

December 10, 2016

Study Completion

December 10, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

NO(1)