Intermittent Versus Continuous Tarceva Study

Intermittent Versus Continuous Erlotinib With Concomitant Modified 'Xelox' (q3W) in First-line Treatment of Metastatic Colorectal Cancer

This is a randomized phase II study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Chemotherapy

Detailed Description

To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years.
• ECOG performance status of 0-2.
• Histological proof of adenocarcinoma of colon or rectum with evidence of metastatic disease.
• At least one unidimensionally measurable lesion with a diameter >20 mm using conventional CT or MRI scans, or > 10 mm with spiral CT
• No prior drug treatment or chemotherapy for metastatic disease.
• No prior HER2 or EGFR inhibitors. No prior Oxaliplatin in any clinical setting.
• Absolute granulocyte count > 1.5 x 109/L, platelet count > 100 x 109/L, hemoglobin level > 9.0 g/L, INR < 1.5.
• Adequate renal & hepatic functions: serum creatinine < 1.5 x upper limit of normal (ULN) or calculated creatinine clearance > 50ml/min, serum bilirubin < 1.5 x ULN, ALT < 2.5 x ULN or < 5 x ULN in case of liver metastases, albumin level > 30g/dL).
• Prior adjuvant or neoadjuvant chemotherapy for non-metastatic CRC is allowed if > 3 months has elapsed since the last dose of chemotherapy.
• Prior open surgery is allowed if > 28 days* has elapsed since the date of surgery, wound healing is satisfactory and recovery from any complications from the surgery is adequate. (*For laparoscopic surgery, > 14 days from the date of surgery).
• No serious medical conditions such as myocardial infarction within 6 months prior to entry, or any other medical conditions that might be aggravated by treatment

Exclusion Criteria:

• Prior history of any malignancies, except basal cell cancer of skin, cervical CIN.
• Treatment with radiotherapy < 30 days.
• Pregnant or lactating females
• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
• Patients who have not recovered from surgery or other medical illness such as infection.
• Evidence of central nervous system disease. Patients with a history of uncontrolled seizures, central nervous disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded from the study
• Patients lacking physical integrity of upper gastrointestinal tract or malabsorption syndrome or unable to swallow tablets.
• Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency).
• Interstitial pneumonia or extensive symptomatic fibrosis of the lungs.
• Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
• Known peripheral neuropathy ≥ NCI CTC grade 1.
• Current or recent (within 10 days prior to study treatment start) use of full-dose oral anticoagulant (e.g. warfarin) or thrombolytic agent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A; Continuous erlotinib administration (21-day cycle). Erlotinib dose given at 100mg daily	Drug: Chemotherapy; Erlotinib, Oxaliplatin, Capecitabine
Active Comparator: Arm B; Intermittent erlotinib administration (21-day cycle). Erlotinib dose given at 150mg.	Drug: Chemotherapy; Erlotinib, Oxaliplatin, Capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate two different schedules of erlotinib and modified XELOX regimen in terms of toxicity, their duration of response and effect on time to progression, progression-free survival and overall survival.	3 years
To determine the effect of intermittent versus continuous erlotinib administration on pharmacodynamic endpoints using tumor biopsies	3 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Brigette Ma, MD, FRACP, Department of Clinical Oncology, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 17, 2010
• First Posted (Estimate): November 18, 2010

Study Record Updates

• Last Update Posted (Estimate): November 22, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Second line treatment for metastatic colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: COL012