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

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Drug: Irinotecan; Drug: Avastin; Drug: Erbitux

• Registration Number: NCT00681876
• Lead Sponsor: Hellenic Oncology Research Group

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Irinotecan	Irinotecan+Avastin+Erbitux
1	Avastin	Irinotecan+Avastin+Erbitux
1	Erbitux	Irinotecan+Avastin+Erbitux

Primary Outcome Measures

Name	Time	Method
Time To Progression	1 year

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Toxicity profile	Toxicity assessment on each chemotherapy cycle
Quality of life, Symptoms improvement	Assessment every two cycles

Trial Locations

Locations (8)

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece

: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

State General Hospital of Larissa; 🇬🇷 Larissa, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece