Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer

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Brief Title

Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer

Official Title

A Phase II Study of Lapatinib and Capecitabine in the Treatment of Metastatic Pancreatic Cancer.

Brief Summary

      RATIONALE: 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.

      PURPOSE: This phase II trial is studying how well giving lapatinib ditosylate together with
      capecitabine works in treating patients with metastatic pancreatic cancer.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  To evaluate the efficacy of lapatinib ditosylate and capecitabine as first-line therapy,
           in terms of overall survival, in patients with metastatic pancreatic cancer.

      Secondary

        -  To evaluate the progression-free survival of patients treated with this regimen.

        -  To evaluate the overall response rate (complete and partial responses) in patients
           treated with this regimen.

        -  To evaluate the clinical benefit (complete response, partial response, or stable disease
           for ≥ 6 months) of this regimen in these patients.

        -  To evaluate the qualitative and quantitative toxicity associated with this regimen in
           these patients.

        -  To determine the intra-tumoral expression of ErbB1 (EGFR) and ErbB2 (HER2/neu) in these
           patients.

        -  To seek pilot information on the intra-tumoral expression of markers of tumor resistance
           and sensitivity to treatment, including resistance drug pump expression and growth
           factor receptor expression.

        -  To collect pre- and post-treatment serum samples from these patients for proteomic
           analyses to elucidate if any serum cancer marker profiles can be detected.

      OUTLINE: This is a multicenter study.

      Patients receive oral lapatinib ditosylate once daily on days 1-21 and oral capecitabine
      twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression
      or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 6-12 weeks.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

6-month survival rate

Secondary Outcome

 Progression-free survival

Condition

Pancreatic Cancer

Intervention

capecitabine

Study Arms / Comparison Groups

 Capecitabine and Lapatinib
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

January 2009


Primary Completion Date

December 2010

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas

          -  Measurable or non-measurable disease

               -  Measurable disease is defined as ≥ 1 lesion that can be accurately measured in ≥
                  1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional
                  techniques or as ≥ 10 mm with spiral CT scan

          -  No known brain metastases or leptomeningeal disease

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Life expectancy > 12 weeks

          -  ANC ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9 g/dL

          -  Albumin ≥ 2.5 g/dL

          -  Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times ULN if Gilbert's
             syndrome is present)

          -  AST and ALT ≤ 3 times ULN (5 times ULN if documented liver metastases are present)

          -  Creatinine < 1.5 times ULN

          -  Cardiac ejection fraction normal by ECHO or MUGA scan

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to swallow and retain oral medication

          -  No gastrointestinal (GI) tract disease resulting in an inability to take oral
             medication, malabsorption syndrome, requirement for IV alimentation, or uncontrolled
             inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)

          -  No active hepatic or biliary disease, except for Gilbert's syndrome, asymptomatic
             gallstones, liver metastases, or stable chronic liver disease per investigator
             assessment

          -  No active cardiac disease within the past 6 months, including any of the following:

               -  Uncontrolled angina

               -  Clinically significant arrhythmia, except for asymptomatic atrial fibrillation
                  requiring anticoagulation

               -  Myocardial infarction

               -  Uncontrolled or symptomatic congestive heart failure

               -  Any other cardiac condition that, in the opinion of the treating physician, would
                  make this study unreasonably hazardous for the patient

          -  No concurrent uncontrolled illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situation that would limit compliance with
             study requirements

          -  No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
             chemically related to lapatinib ditosylate or any of its excipients, capecitabine, or
             fluorouracil

          -  No known dihydropyrimidine dehydrogenase (DPD) deficiency

          -  No other malignancy within the past 5 years except for completely resected nonmelanoma
             skin cancer or successfully treated in situ carcinoma

        PRIOR CONCURRENT THERAPY:

          -  Recovered from prior radiotherapy or surgery

          -  No prior surgical procedures affecting absorption

          -  No prior EGFR- or ErbB2-targeting therapies

          -  No prior capecitabine

          -  No prior chemotherapy for locally advanced or metastatic pancreatic cancer

          -  At least 3 months since prior adjuvant chemotherapy

               -  Prior fluorouracil allowed as a radiosensitizer only

          -  More than 30 days (or 5 half-lives) since prior investigational drugs

          -  No concurrent radiotherapy or surgery for metastatic cancer

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent CYP3A4 inducers or inhibitors

          -  No other concurrent investigational agents or anticancer therapy (e.g., cytotoxic or
             biologic therapy)

          -  No concurrent herbal (alternative) medicines
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ray McDermott, MD, , 

Location Countries

Ireland

Location Countries

Ireland

Administrative Informations


NCT ID

NCT00962312

Organization ID

08-39 ICORG

Secondary IDs

ICORG-08-39

Responsible Party

Sponsor

Study Sponsor

Cancer Trials Ireland


Study Sponsor

Ray McDermott, MD, Principal Investigator, Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital


Verification Date

October 2012