Phase II Study of Avastin + Erbitux + Irinotecan as 2nd Line Treatment of Colorectal Cancer

NCT ID: NCT00681876

Last Updated: 2013-02-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-02-28

Brief Summary

This phase II study will evaluate the efficacy of the combination of two monoclonal antibodies (Avastin + Erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with FOLFIRI Avastin or XELIRI Avastin.

Detailed Description

Treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. The reported data demonstrated that addition of ERBITUX may reverse IRINOTECAN resistance. Further data support the feasibility of the combination of two monoclonal antibodies (AVASTIN+ERBITUX) with IRINOTECAN with better responses compared to historical controls (ERBITUX±IRINOTECAN). As such, a phase II study was designed to evaluate the efficacy of the combination of AVASTIN plus ERBITUX plus IRINOTECAN as second line treatment in patients progressing while on treatment with FOLFIRI AVASTIN or XELIRI AVASTIN

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Irinotecan+Avastin+Erbitux

Group Type: EXPERIMENTAL

Irinotecan

Intervention Type: DRUG

Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

Avastin

Intervention Type: DRUG

Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression

Erbitux

Intervention Type: DRUG

Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression

Interventions

Irinotecan

Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

Intervention Type: DRUG

Avastin

Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression

Intervention Type: DRUG

Erbitux

Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression

Intervention Type: DRUG

Other Intervention Names

CPT-11; Campto; Bevacizumab; Cetuximab

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed locally advanced or metastatic colorectal cancer.
• Measurable or evaluable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
• ECOG performance status ≤ 2
• Age 18 - 72 years
• Patients with de novo refractory disease (progression of disease as best response at 1st line therapy with FOLFOX/Avastin)
• Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL),renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥100,000/mm3) function
• Patients must be able to understand the nature of this study
• Written informed consent

Exclusion Criteria

• History of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias).
• History of myocardial infarction or stroke within 6 months.
• Clinically significant peripheral vascular disease.
• History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to Day 0.
• Presence of central nervous system or brain mets.
• Evidence of bleeding diathesis or coagulopathy.
• Patients with known hypersensitive reaction to cetuximab
• Blood pressure > 150/100 mmHg.
• Pregnant or lactating woman.
• Life expectancy < 3 months.
• Previous radiotherapy within the last 4 weeks or > 25% of bone marrow.
• Metastatic infiltration of the liver >50%.
• Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy.
• Active infection requiring antibiotics on Day 1.
• Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
• Psychiatric illness or social situation that would preclude study compliance.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 72 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Crete

OTHER

Sponsor Role: collaborator

Hellenic Oncology Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Souglakos, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Crete

Locations

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, , Greece

401 Military Hospital of Athens

Athens, , Greece

: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, , Greece

Air Forces Military Hospital of Athens

Athens, , Greece

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, , Greece

State General Hospital of Larissa

Larissa, , Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, , Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

CT/05.32

Identifier Type: -

Identifier Source: org_study_id