Intermittent Versus Continuous Tarceva Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01243047
First received: November 17, 2010
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermittent Versus Continuous Erlotinib With Concomitant Modified 'Xelox' (q3W) in First-line Treatment of Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

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 ]

Enrollment: 60
Study Start Date: September 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243047

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Brigette Ma, MD, FRACP Department of Clinical Oncology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01243047     History of Changes
Other Study ID Numbers: COL012
Study First Received: November 17, 2010
Last Updated: November 20, 2012
Health Authority: 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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014