- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00574171
Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma
December 11, 2019 updated by: University of Wisconsin, Madison
A Phase II Trial of Lapatinib and Capectiabine for Patients With Refractory Advanced Colorectal Adenocarcinoma (LAP109859)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- To evaluate the response rate of lapatinib and capecitabine combination in patients with metastatic colon or rectal cancer.
- To evaluate the toxicity and tolerability of lapatinib and capecitabine in this population.
- To determine overall survival and disease free survival of lapatinib and capecitabine.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1250mg by mouth daily one hour before or after breakfast on a continuous basis.
Other Names:
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response Rate of Lapatinib/Capecitabine.
Time Frame: duration of study; on average 1 year
|
duration of study; on average 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Alcee J Jumonville, M.D., Gunderson Lutheran - LaCrosse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
December 13, 2007
First Submitted That Met QC Criteria
December 14, 2007
First Posted (Estimate)
December 17, 2007
Study Record Updates
Last Update Posted (Actual)
December 18, 2019
Last Update Submitted That Met QC Criteria
December 11, 2019
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CO 07201
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- LAP109859 (Other Grant/Funding Number: Glaxo Smith Kline)
- NCI-2011-00477 (Registry Identifier: NCI Trial ID)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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