Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00574171
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : July 14, 2015
Last Update Posted : March 21, 2016
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this study is to find out how effective this combination is as a second line treatment for colorectal cancer that has spread from one part of the body to another (metastasized) or has not metastasized but is considered inoperable (unable to be removed by surgery). The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: lapatinib Drug: Capecitabine Phase 2

Detailed Description:
  1. To evaluate the response rate of lapatinib and capecitabine combination in patients with metastatic colon or rectal cancer.
  2. To evaluate the toxicity and tolerability of lapatinib and capecitabine in this population.
  3. To determine overall survival and disease free survival of lapatinib and capecitabine.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Lapatinib and Capectiabine for Patients With Refractory Advanced Colorectal Adenocarcinoma (LAP109859)
Study Start Date : September 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: lapatinib
1250mg by mouth daily one hour before or after breakfast on a continuous basis.
Other Name: Tykerb
Drug: Capecitabine
2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
Other Name: Xeloda

Primary Outcome Measures :
  1. Response Rate of Lapatinib/Capecitabine. [ Time Frame: duration of study; on average 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years
  • Pathologically confirmed, locally advanced or metastatic adenocarcinoma of the colon or rectum
  • Patients must have had progression of disease on prior therapy with an oxaliplatin-containing or irinotecan containing regimen
  • Proper radiographic documentation of measurable disease using RECIST criteria
  • ECOG performance status (PS) of 0 or 1
  • Laboratory parameters:

Hgb: ≥ 9.0 g/dl ANC ≥ 1500/ul Platelet ≥ 100,000/ul Creatinine ≤ 2x ULN OR Creatinine clearance ≥ 30 mg/ml Bilirubin ≤ 2x ULN AST ≤ 2x ULN or 5X ULN if liver metastases are present

  • Patient has signed informed consent
  • Toxicities from prior therapy (except alopecia and neuropathy) must have resolved to grade 1 or better prior to enrollment

Exclusion Criteria:

  • Administration of more than one prior systemic chemotherapy for metastatic disease
  • Pregnant or breast-feeding women: female patients must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. All at-risk female patients must have a negative serum pregnancy test within 7 days prior to randomization.
  • Active inflammatory bowel disease, significant bowel obstruction, or chronic diarrhea (grade 2).
  • Known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
  • No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years.
  • Known CNS metastases
  • Prior therapy which specifically and directly targets the EGFR pathway
  • Significant history of uncontrolled cardiovascular disease, defined as:

    • History of uncontrolled or symptomatic angina
    • History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
    • Myocardial infarction < 6 months prior to study entry
    • Cerebrovascular accident <6 months prior to study entry
    • Uncontrolled or symptomatic congestive heart failure
    • Ejection fraction below the institutional normal limit
    • Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00574171

United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Study Chair: Alcee J Jumonville, M.D. Gunderson Lutheran - LaCrosse

Responsible Party: University of Wisconsin, Madison Identifier: NCT00574171     History of Changes
Other Study ID Numbers: CO07201 (LAP109859)
First Posted: December 17, 2007    Key Record Dates
Results First Posted: July 14, 2015
Last Update Posted: March 21, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors