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

Hellenic Oncology Research Group

Status and phase

Terminated

Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: Erbitux

Drug: Avastin

Drug: Irinotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT00681876

CT/05.32

Details and patient eligibility

About

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.

Full 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

Enrollment

16 patients

Sex

All

Ages

18 to 72 years old

Volunteers

No Healthy Volunteers

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.