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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


Phase 2
18 Years
72 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time To Progression

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

John Souglakos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/05.32

NCT ID:

NCT00681876

Start Date:

April 2008

Completion Date:

February 2010

Related Keywords:

  • Colorectal Cancer
  • Metastatic colorectal cancer
  • Second line
  • Irinotecan
  • Erbitux (Cetuximab)
  • Avastin (Bevacizumab)
  • Colorectal Neoplasms

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