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Status:

COMPLETED

Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer

Lead Sponsor:

Cancer Trials Ireland

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 s...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    9 Patients enrolled

    Trial Details

    Trial ID

    NCT00962312

    Start Date

    January 1 2009

    Last Update

    December 31 2014

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Cork University Hospital

    Cork, Ireland

    2

    Mercy University Hospital

    Cork, Ireland

    3

    Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

    Dublin, Ireland, 24

    4

    St. Vincent's University Hospital

    Dublin, Ireland, 4

    Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer | DecenTrialz