Lapatinib Ditosylate and Capecitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive18 and over2008-437
NCI-2013-00670, NCT00881621

Trial Description


This phase II trial studies how well lapatinib ditosylate and capecitabine works in treating patients with locally advanced or metastatic pancreatic cancer. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib ditosylate together with capecitabine may kill more tumor cells.

Further Study Information


I. To assess the efficacy of lapatinib (lapatinib ditosylate) and capecitabine as 2nd line therapy in metastatic pancreatic cancer in terms of overall survival.


I. To assess secondary efficacy endpoints of the regimen including clinical benefit response, progression free survival, and objective response rate.

II. To evaluate the toxicity of the combination of lapatinib and capecitabine in the pancreatic cancer patient population.

III. To identify intratumoral biomarkers which correlate with or are predictive of clinical outcome, including expression of epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER-2), phosphorylated mitogen activated protein kinase (MAPK), phosphorylated extracellular-signal-regulated kinase (ERK), signal transducer and activator of transcription 5 (STAT5), AKT3, and KRAS, phosphatidylinositol 3' -kinase (PI3K) mutation analysis.

IV. To explore the usage of circulating tumor cells (CTC) in predicting clinical response of pancreatic cancer to chemotherapy.

V. Together with the companion exploratory protocol, assess the feasibility of propagating human tumor from biopsy implanted in nude mice and isolating pancreas stem cells.


Patients receive lapatinib ditosylate orally (PO) on days 1-21 and capecitabine PO twice daily (BID) on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 6 months.

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the pancreas

Prior failed 1st line gemcitabine therapy for metastatic disease, or relapsed within six months since completion of gemcitabine adjuvant therapy; failure is defined as radiological or clinical progression or documented unacceptable toxicity

Prior capecitabine or 5FU is allowed (but not required) in the setting of radiation

Radiographically measurable disease

Must either be able to swallow and/or receive enteral medication via gastrostomy feeding tumor (subjects who are nulla per os [NPO] will only be deemed eligible after approval by the Principal Investigator)

Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram (multigated acquisition [MUGA] scan may be performed if echocardiogram [ECHO] is not available)

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Signed informed consent form

Absolute neutrophil count (ANC) >= 1500/mm^3

Platelets >= 100,000/m^3

Serum total bilirubin =< 1.5 x upper limit of normal (ULN)

Aspartate aminotransaminase (AST) and alanine aminotransferase (ALT) =< 3.0 x ULN unless liver metastases are present, in which case =< 5.0 x ULN

Creatinine clearance >= 30 mL/min

Ejection fraction > 50% (based on 2-dimensional (2-D) ECHO or MUGA scan)

Exclusion Criteria:

Any prior treatment with lapatinib, or any anti-HER2 treatment or any anti-EGFR treatment

Patients have not recovered from adverse events to a toxicity grade =< 1 due to prior chemotherapy

More than one prior chemotherapy regimen

Patients with known brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis will be excluded from this clinical trial because of their poor prognosis or because they often develop progressive neurological dysfunction that would confound the evaluation of other adverse events

Human immunodeficiency virus (HIV) positive patients on antiretroviral therapy (to avoid potential for drug interactions)

Women who are pregnant or lactating; women and men of child-bearing potential who are not using a reliable form of contraception

History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or capecitabine

Malabsorption syndrome or uncontrolled inflammatory gastrointestinal (GI) disease (Crohn's or ulcerative colitis)

Known history of uncontrolled or symptomatic angina, arrhythmia, or congestive heart failure (atrial fibrillation is allowed if the heart rate is under control)

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 (DPD) deficiency

Concurrent malignancy (i.e., malignancy other than adenocarcinoma of the pancreas), unless

The subject has been curatively treated and disease free for >= 2 years, or

The cancer has non-melanoma skin cancer or early cervical cancer

Creatinine clearance < 30 mL/min as calculated by the Cockroft-Gault equation

ANC < 1500

Platelets < 75,000

Transaminases > 3.0 times the upper limit of normal (ULN), except in known hepatic metastasis, wherein they must be =< 5.0 x ULN

Total bilirubin > 1.5 times the ULN, > 2.5 x ULN if patient has Gilbert's syndrome

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

MedStar Georgetown University Hospital

  • National Cancer Institute
Aiwu Ruth He, Principal Investigator

Trial Sites


District of Columbia

MedStar Georgetown University Hospital

Aiwu Ruth He
Ph: 202-444-0381

Aiwu Ruth He
Principal Investigator

Link to the current record.
NLM Identifier NCT00881621

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