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

This study has been terminated.
(Due to poor accrual)
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00681876
First received: May 19, 2008
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: Irinotecan
Drug: Avastin
Drug: Erbitux
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Time To Progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Quality of life, Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: April 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Irinotecan+Avastin+Erbitux
Drug: Irinotecan
Irinotecan (IV) 150 mg/m2 on day 1 every two weeks until progression
Other Names:
  • CPT-11
  • Campto
Drug: Avastin
Avastin (IV) 10 mgr/Kgr on day 1 every 2 weeks until progression
Other Name: Bevacizumab
Drug: Erbitux
Erbitux (IV)500 mg/m2 on day 1 every two weeks until progression
Other Name: Cetuximab

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

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681876

Locations
Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
: "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
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, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: John Souglakos, MD University Hospital of Crete
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00681876     History of Changes
Other Study ID Numbers: CT/05.32
Study First Received: May 19, 2008
Last Updated: February 12, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Metastatic colorectal cancer
Second line
Irinotecan
Erbitux (Cetuximab)
Avastin (Bevacizumab)

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Cetuximab
Irinotecan
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 02, 2014