Intermittent Versus Continuous Tarceva Study
This study has been completed.
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
First received: November 17, 2010
Last updated: November 20, 2012
Last verified: November 2012
This is a randomized phase II study comprising of two treatment arms in patients who are previously untreated for metastatic or recurrent colorectal cancer.
Metastatic Colorectal Cancer
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Intermittent Versus Continuous Erlotinib With Concomitant Modified 'Xelox' (q3W) in First-line Treatment of Metastatic Colorectal Cancer
Primary Outcome Measures:
- To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To determine the effect of intermittent versus continuous erlotinib administration on pharmacodynamic endpoints using tumor biopsies [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2012 (Final data collection date for primary outcome measure)
Active Comparator: Arm A
Continuous erlotinib administration (21-day cycle). Erlotinib dose given at 100mg daily
Erlotinib, Oxaliplatin, Capecitabine
Active Comparator: Arm B
Intermittent erlotinib administration (21-day cycle). Erlotinib dose given at 150mg.
Erlotinib, Oxaliplatin, Capecitabine
To evaluate two different schedules of erlotinib in combination with a modified XELOX regimen in terms of response rate
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
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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: NCT01243047
|Department of Clinical Oncology, Prince of Wales Hospital
|Hong Kong, Hong Kong |
Chinese University of Hong Kong
||Brigette Ma, MD, FRACP
||Department of Clinical Oncology, The Chinese University of Hong Kong
No publications provided
||CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 17, 2010
||November 20, 2012
||Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Keywords provided by Chinese University of Hong Kong:
Second line treatment for metastatic colorectal cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 20, 2014
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action