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

NCT00681876 | Terminated Phase 2

• 1 other identifier: CT/05.32
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 8

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.

Conditions

Colorectal Cancer

Keywords

Metastatic colorectal cancer; Second line; Irinotecan; Erbitux (Cetuximab); Avastin (Bevacizumab)

Outcome Measures

Primary Outcomes (1)

• Time To Progression

  1 year

Secondary Outcomes (3)

• 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

Study Arms (1)

1

EXPERIMENTAL

Irinotecan+Avastin+Erbitux

Drug: Irinotecan; Drug: Avastin; Drug: Erbitux

Interventions

Irinotecan DRUG

Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression

Also known as: CPT-11, Campto

1

Avastin DRUG

Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression

Also known as: Bevacizumab

1

Erbitux DRUG

Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression

Also known as: Cetuximab

1

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (8)

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

State General Hospital of Larissa

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Bevacizumab; Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• John Souglakos, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 13, 2013

Record last verified: 2013-02

Locations

GR (8)