Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer

TRIAL ALERTS

View Clinical Trial (Medical Research Study)

City:		Washington
State:		District of Columbia
Zip Code:		20007

Conditions:		Pancreas Cancer
Purpose:		Patients are being asked to participate in this study who have locally advanced or metastatic pancreatic cancer (cancer of the pancreas that has spread to another part of the body) that has gotten worse after first-line chemotherapy. The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two chemotherapy agents), prolong survival and improve quality of life as compared to supportive care alone. Lapatinib in combination with a drug called capecitabine, has been approved by the Food and Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been approved to treat this type of cancer. Both of these drugs are pills. This research is being done because it is not known if the combination of Capecitabine and Lapatinib is better than supportive care alone for pancreatic cancer.
Study Summary:		This is an open-label single-arm Phase II trial for patients with metastatic pancreatic cancer who have failed first line Gemcitabine-based therapy. Patients will be treated with a combination of Capecitabine and Lapatinib, a dual tyrosine-kinase inhibitor of EGFR and HER-2.
Criteria:		Inclusion Criteria: - Histologically confirmed adenocarcinoma of the pancreas - Prior failed 1st line gemcitabine therapy for metastatic disease or relapsed within six months of completion of gemcitabine adjuvant therapy - Prior capecitabine or 5fu is allowed in the setting of radiation - Must either be able to swallow or receive enteral nutrition via gastrostomy feeding tube - Cardiac ejection fraction within institutional range of normal as measured by echocardiogram - ECOG performance status 0-2 - Signed informed consent form - Adequate hepatic, bone marrow, and renal function Exclusion Criteria: - Any prior treatment with lapatinib, or any anti-HER2 treatment or any anti-EGFR treatment - Not recovered from adverse events to a toxicity grade </= 1 due to prior chemotherapy - More than one prior chemotherapy regimens - Known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis - HIV positive on antiretroviral therapy - Pregnant or lactating - History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or capecitabine - Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative colitis) - Known history of uncontrolled or symptomatic angina, arrhythmia, or congestive heart failure - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/ social situations that would limit compliance with study requirements - Known dihydropyrimidine dehydrogenase deficiency - Concurrent malignancy unless the subject has been curatively treated and disease free for >/= 2 years or the cancer was non-melanoma skin cancer or early cervical cancer. - Creatinine clearance < 30 mL/min - Absolute neutrophil count < 1500, platelets < 75,000 - Transaminases > 3.0 times the upper limit of normal, except in known hepatic metastasis, wherein they must be < 5.0 times the upper limit of normal - Total bilirubin > 1.5 times the ULN, > 2.5 x ULN if patient has Gilbert's syndrome
NCT ID:		NCT00881621
Primary Contact:		Principal Investigator Ruth He, MD, PhD Georgetown University Lisa Ley, MSN Phone: 202-687-6533 Email: leyl@georgetown.edu
Backup Contact:		N/A
Location Contact:		Washington, District of Columbia 20007 United States Lisa Ley, MSN Phone: 202-687-6533 Email: leyl@georgetown.edu Site Status: Recruiting

Data Source:		ClinicalTrials.gov
Date Processed:		May 23, 2013
Modifications to this listing:		Only selected fields are shown, please use the link below to view all information about this clinical trial.
Click to view Full Listing


If you would like to be contacted by the clinical trial representative please enter your contact information, then click "I Am Interested In This Study"

First Name:

Last Name:

Email Address:

Confirm Email:

Daytime Phone (eg. 555-555-5555):

City:

State:

Zip Code:

Best Time to Call:

Morning	Afternoon	Evening
Please contact me by email instead of calling.

Questions/Comments:

I have read and agree with the Privacy Policy

I have reviewed the eligibility criteria and believe I am eligible for this clinical trial

I would like to be notified about new clinical trials.

NEARBY STUDIES

Within 25 Miles

Crohn's Disease - Chevy Chase MD

Crohn's Disease - Annapolis MD

Healthy Volunteers (Ages 18-50) - Bethesda MD

Alcohol - Bethesda MD

Irritable Bowel Syndrome with Diarrhea (IBS-D) - Chevy Chase MD

G6PD Deficient Adults (Ages 18 to 62) - Silver Spring MD

Excessive Daytime Sleepiness with Narcolepsy - Chevy Chase MD

Restless Legs Syndrome (RLS) - Chevy Chase MD

Irritable Bowel Syndrome (with diarrhea) - Annapolis MD

Gout - Manassas VA

Anti-Depressant Induced Sexual Dysfunction - Washington DC

Anti-Depressant Induced Sexual Dysfunction - Gaithersburg MD

Asthma (Ages 18-65) - Wheaton MD

Brain Tumor (Glioblastoma) - Bethesda MD

Crohn’s Disease or Ulcerative Colitis - Bethesda MD

Healthy Volunteers (Ages 18-50) - Silver Spring MD

Within 50 Miles

Type 2 Diabetes - Baltimore MD

Healthy Volunteers (Ages 18-75) - Baltimore MD

Smoking - Baltimore MD

Multiple Sclerosis - Baltimore MD

Orthostatic Hypotension - Baltimore MD

Chronic Fatigue Syndrome - Baltimore MD

Irritable Bowel Syndrome with Diarrhea (IBS-D) - Towson MD

Arthritis - Frederick MD

Parkinson's Disease - Baltimore MD

Postherpetic Neuralgia (Post-Shingles Pain) - Towson MD

Excessive Daytime Sleepiness with Narcolepsy - Towson MD

Smoking - Baltimore MD

Osteoarthritis of the Knee - Towson MD

Multiple Sclerosis - Baltimore MD

Asthma (Ages 18-65) - White Marsh MD

Anti-Depressant Induced Sexual Dysfunction - Baltimore MD

Alzheimer's Disease - Towson MD

Methamphetamine Use - Baltimore MD

Healthy Volunteers (Ages 18-65) - Baltimore MD

Orthostatic Hypotension (Low Blood Pressure Upon Standing) - Baltimore MD

Alzheimer's Disease - Baltimore MD

Memory Loss - Baltimore MD

Within 100 Miles

Emphysema/COPD (Chronic Obstructive Pulmonary Disease) - Richmond VA

Pediatric Depression - Richmond VA

Polycystic Ovary Syndrome - Richmond VA

Arthritis - Hagerstown MD

Restless Legs Syndrome (RLS) - Charlottesville VA

Irritable Bowel Syndrome (with diarrhea) - Richmond VA

Irritable Bowel Syndrome (with diarrhea) - Richmond VA

Anti-Depressant Induced Sexual Dysfunction - Charlottesville VA

COPD (Emphysema and Chronic Bronchitis) - Richmond VA1

COPD (Emphysema and Chronic Bronchitis) - Richmond VA3

Chronic Obstructive Pulmonary Disorder (COPD) - Richmond VA

Eczema - Henrico VA

TRIAL ALERTS

HEALTH NEWS

RSS FEEDS

ABOUT TRIALS

LINK TO US

View Clinical Trial (Medical Research Study)

NEARBY STUDIES