Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer - Full Text View

Sponsors and Collaborators:	Georgetown University GlaxoSmithKline
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00881621

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.

Condition	Intervention	Phase
Pancreas Cancer	Drug: Lapatinib and Capecitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Capecitabine Lapatinib Lapatinib Ditosylate

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:

Overall survival [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical benefit response [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Objective Response [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	51
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lapatinib and Capecitabine: Experimental Treatment	Drug: Lapatinib and Capecitabine Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles

Detailed Description:

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881621

Contacts

Contact: Lisa Ley, MSN

202-687-6533

leyl@georgetown.edu

Locations

United States, District of Columbia
Georgetown University Medical Center	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Lisa Ley, MSN 202-687-6533 leyl@georgetown.edu
Principal Investigator: Ruth He, MD PhD

Sponsors and Collaborators

Georgetown University

GlaxoSmithKline

Investigators

Principal Investigator:

Ruth He, MD, PhD

Georgetown University

More Information

No publications provided

Responsible Party:	Georgetown University Medical Center ( Aiwu Ruth He, MD, PhD )
Study ID Numbers:	011438, IND #103,981, 2008-437
Study First Received:	April 13, 2009
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00881621 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Georgetown University:

Pancreas cancer
lapatinib
capecitabine

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Lapatinib
Pancrelipase

Protein Kinase Inhibitors
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Endocrine System Diseases
Enzyme Inhibitors

Lapatinib
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 04, 2009