Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

This study has been terminated.
(slow enrollment)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ruth He, Georgetown University
ClinicalTrials.gov Identifier:
NCT00881621
First received: April 13, 2009
Last updated: March 23, 2014
Last verified: March 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ]

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

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
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, see Learn About Clinical Studies.

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

No publications provided

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, 2008-437
Study First Received: April 13, 2009
Last Updated: March 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Fluorouracil
Lapatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014