Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab (Erbitux) or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Pte. Ltd., Singapore
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00778830
First received: October 22, 2008
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

This is an open-label, non-randomized, multicenter phase II study evaluating FOLFIRI plus cetuximab or FOLFOX plus cetuximab as first-line therapy of patients with KRAS wild-type metastatic colorectal cancer.

Only subjects with KRAS wild-type tumors are eligible. Efficacy will be assessed every 8 weeks. Treatment will be continued until progressive disease or unacceptable adverse events occur. After the end of study treatment, information on further anticancer treatment and survival will be collected every 3 months.


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Erbitux
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Asia Pacific Non-randomized, Open-label Phase II Study Evaluating the Safety and Efficacy of FOLFIRI Plus Cetuximab (Erbitux) or FOLFOX Plus Cetuximab as First-line Therapy in Subjects With KRAS Wild-type Metastatic Colorectal Cancer (APEC-Study)

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Every 8 weeks during study participation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival Overall Survival Safety [ Time Frame: Entire study participation ] [ Designated as safety issue: Yes ]

Enrollment: 288
Study Start Date: February 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erbitux

    Erbitux 500mg/m2 biweekly on day 1 in combination with modified FOLFIRI regimen or modified FOLFOX regimen given biweekly:

    Option 1 (FOLFIRI) Irinotecan 180 mg/m² on day 1 Folinic acid 400 mg/m² (racemic) or 200 mg/m² (L-form) on day 1 5-Fluorouracil 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m²

    Option 2 (FOLFOX) Oxaliplatin 100 mg/m² on day 1 Folinic acid 400 mg/m² (racemic) or 200 mg/m² (L-form) on day 1 5-Fluorouracil 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m²

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Signed written informed consent

  • Inpatient or outpatient subjects, 18 years of age
  • Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
  • Metastatic disease (M1)
  • Life expectancy of at least 12 weeks
  • Presence of at least 1 measurable index lesion (not lie in an irradiated area) by CT scan or MRI
  • ECOG performance status of 0 or 1 at study entry
  • Effective contraception for both male and female subjects if the risk of conception exists
  • White blood cell count ≥ 3,000/mm3 with neutrophils ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
  • Total bilirubin ≤ 1.5 x upper reference range
  • AST ≤ 2.5x upper reference range, or ≤ 5x upper reference range in case of liver metastasis
  • Serum creatinine ≤ 1.5x upper reference range
  • Recovery from relevant toxicity to previous treatment before study entry
  • KRAS wild-type status of tumor tissue

Exclusion Criteria:

  • Previous chemotherapy for colorectal cancer except adjuvant treatment if terminated > 6 months before the start of treatment in this study
  • Radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study
  • Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy, or EGFR-pathway targeting therapy not indicated in this study protocol
  • Concurrent hormone therapy not indicated in this study protocol except for physiologic replacement or contraception
  • Known hypersensitivity reaction to any of the components of study treatments
  • Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
  • Brain metastasis and/or leptomeningeal disease (known or suspected)
  • Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
  • Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
  • Peripheral neuropathy > grade 1
  • Previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
  • Known alcohol or drug abuse
  • Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
  • Participation in another clinical study within the past 30 days
  • Significant disease which, in the investigator's opinion, would exclude the patient from the study
  • Legal incapacity or limited legal capacity
  • KRAS mutated status of tumor tissue
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778830

Locations
Singapore
Research Site
Singapore, Singapore
Sponsors and Collaborators
Merck KGaA
Merck Pte. Ltd., Singapore
Investigators
Principal Investigator: Andrew Ann-Lii Cheng, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00778830     History of Changes
Other Study ID Numbers: EMR 62202-505
Study First Received: October 22, 2008
Last Updated: September 24, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
China: Food and Drug Administration
Hong Kong: Department of Health
India: Drugs Controller General of India
Indonesia: Indonesia Drugs and Foods Regulatory Authority
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Singapore: Health Sciences Authority
Taiwan: Department of Health
Thailand: Food and Drug Administration
Pakistan: Ministry of Health
Philippines: Bureau of Food and Drugs

Keywords provided by Merck KGaA:
mCRC

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
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014