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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)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

Every 8 weeks during study participation

Safety Issue:

No

Principal Investigator

Andrew Ann-Lii Cheng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

EMR 62202-505

NCT ID:

NCT00778830

Start Date:

February 2009

Completion Date:

June 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • mCRC
  • Colorectal Neoplasms

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