Irinotecan, Cetuximab and Everolimus to Patients With Metastatic Colorectal Cancer

NCT01387880 | Completed Phase 2 DMC

• 1 other identifier: GI 0923 ICE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open, multicenter phase II trial of therapy with a combination of cetuximab, and irinotecan every second week combined with a daily dose of everolimus to patients with metastatic colorectal cancer with Kirsten rat sarcoma viral oncogene (KRAS) mutation or to patients resistent to cetuximab and irinotecan therapy for metastatic colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic colorectal cancer; Third line therapy; Fourth line therapy; KRAS mutation status; Cetuximab; Everolimus; Irinotecan

Outcome Measures

Primary Outcomes (1)

• Clinical benefit (SD+PR+CR)

  Clinical benefit is defined as the number of patients with stable disease lasting 2 months and partial response and CR as defined in RECIST 1.1

  1 year

Study Arms (2)

Cetuximab, everolimus, irinotecan

EXPERIMENTAL

Drug: Everolimus

Cetuximab, everolimus and Irinotecan.

ACTIVE COMPARATOR

Patients with metastatic colorectal cancer with KRAS mutant tumours are treated with cetuximab, everolimus and irinotecan. Patients with KRAS wildtype colorectal cancer that have progressed on therapy with cetuximab and irinotecan are treated with cetuximab, irinotecan and everolimus.

Drug: Everolimus

Interventions

Everolimus DRUG

Patients with KRAS mutant tumours are treated with cetuximab, everolimus and irinotecan as third line. Patients with KRAS wildtype tumours that have progressed on therapy with cetuximab and irinotecan are treated with cetuximab, everolimus and Irinotecan.

Cetuximab, everolimus, irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a histological or cytological verified adenocarcinoma of the colon or rectum with non-resectable or metastatic cancer.
• Patients with measurable disease without previous radiotherapy
• Patients with metastatic colorectal cancer with progression after previous therapy with 5-fluoropyrimidines, oxaliplatin or irinotecan. Patients should have been treated with oxaliplatin, but if oxaliplatin has be contraindicated or not tolerated the patient can participate in the trial.
• Patients with KRAS-mutation in their primary tumour or metastasis.
• Patients with progression after therapy with irinotecan or cetuximab independent of KRAS mutation status.
• Previous radiotherapy is allowed to less than 25 % of the bone marrow.
• Age more or equal to 18 years.
• Performance status less than 3.
• An expected survival time of at least 3 months.
• Signed informed consent according to specifications from the ethical comites.

You may not qualify if:

• Former or other concurrent malignant disease except treated basal cell carcinoma or in situ cervical cancer.
• No former therapy with everolimus or other rapamycin as sirolimus or temsirolimus.
• No known hypersensitivity for one or more components in the therapy.
• No uncontrolled diabetes
• No ongoing bleeding or pathological condition associated with a risk of bleeding.
• No liver disease as cirrhose, chronical active hepatitis or chronic persistent hepatitis.
• No gastrointestinal disturbances in function that might cause a major change in the absorption of everolimus as ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome.
• No planned immunisation with attenuated virus in the study period.
• Patients that is unable to follow treatment or evaluation plan.
• Every condition or therapy that after the judgement of investigator might infer the patient a risk or influence the trials objective.
• Pregnant or breastfeeding women.
• At fertile women this is insured by a negative test of pregnancy or use of a safe anticonception during the trial period and at least 3 months after end of treatment.
• Patients with active infections or other serious medical co-morbidity, that might prevent the patient from being treated with the protocoled therapy.
• Incapacitated

Sponsors & Collaborators

• Herlev Hospital: lead
• Odense University Hospital: collaborator
• Aalborg University Hospital: collaborator

Study Sites (1)

Herlev University Hospital

Herlev, Copenhagen, 2730, Denmark

Location

Related Publications (1)

• Spindler KG, Demuth C, Sorensen BS, Johansen JS, Nielsen D, Pallisgaard N, Hoegdall E, Pfeiffer P, Vittrup Jensen B. Total cell-free DNA, carcinoembryonic antigen, and C-reactive protein for assessment of prognosis in patients with metastatic colorectal cancer. Tumour Biol. 2018 Nov;40(11):1010428318811207. doi: 10.1177/1010428318811207.

  PMID: 30486767 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Benny V Jensen, MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: onsultant

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 6, 2011
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

DK (1)