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

Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: Irinotecan (Drug); Avastin (Drug); Erbitux (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
John Souglakos, MD, Principal Investigator, Affiliation: University Hospital of Crete


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.

Clinical Details

Official title: Phase II Study of Avastin Plus Erbitux Plus Irinotecan as 2nd Line Treatment of Locally Advanced or Metastatic Colorectal Cancer in Patients Achieving Disease Progression as Best Response After 1st Line Treatment With FOLFIRI+Avastin or XELIRI+Avastin

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time To Progression

Secondary outcome:

Objective Response Rate

Toxicity profile

Quality of life, Symptoms improvement

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


Minimum age: 18 Years. Maximum age: 72 Years. Gender(s): Both.


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


- Psychiatric illness or social situation that would preclude study compliance.

Locations and Contacts

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, 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

Additional Information

Starting date: April 2008
Last updated: February 12, 2013

Page last updated: August 20, 2015

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