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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00681876
• Other study ID #: CT/05.32
• Status: Terminated
• Phase: Phase 2
• First received: May 19, 2008
• Last updated: February 12, 2013
• Start date: April 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2013
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 72 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Irinotecan
Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
• Avastin
Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
• Erbitux
Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	401 Military Hospital of Athens	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

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time To Progression		1 year	No
Secondary	Objective Response Rate		Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)	No
Secondary	Toxicity profile		Toxicity assessment on each chemotherapy cycle	Yes
Secondary	Quality of life, Symptoms improvement		Assessment every two cycles	No