Status:
TERMINATED
Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 wor...
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 Cape...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00881621
Start Date
August 1 2009
End Date
June 1 2013
Last Update
March 3 2025
Active Locations (1)
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1
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007