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Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

This study has been terminated.
(slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00881621
First Posted: April 15, 2009
Last Update Posted: March 6, 2017
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ruth He, Georgetown University
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Ruth He, Georgetown University:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 24 months ]
    Time of study entry to time of death


Secondary Outcome Measures:
  • Clinical Benefit Response [ Time Frame: 3 months ]

    number of participants who had stable disease or partial response or complete response per Response Evaluation Criteria In Solid Tumors.

    Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

    Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.


  • Progression Free Survival [ Time Frame: 24 months ]
    Time of study entry to cancer progression.

  • Adverse Events [ Time Frame: 2 years ]
    Grade 3 or 4 toxicities


Enrollment: 17
Study Start Date: August 2009
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lapatinib and Capecitabine
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
Other Names:
  • Tykerb
  • GW572016

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00881621


Locations
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
GlaxoSmithKline
Investigators
Principal Investigator: Ruth He, MD, PhD Georgetown University
  More Information

Responsible Party: Ruth He, Assistant Professor of Medicine, Georgetown University
ClinicalTrials.gov Identifier: NCT00881621     History of Changes
Other Study ID Numbers: 011438
IND #103,981 ( Other Identifier: FDA )
2008-437 ( Other Identifier: IRB )
First Submitted: April 13, 2009
First Posted: April 15, 2009
Results First Submitted: March 15, 2015
Last Update Posted: March 6, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ruth He, Georgetown University:
Pancreas cancer
lapatinib
capecitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors