Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer

NCT00962312 | Completed Phase 2

• 4 other identifiers: 08-39 ICORGICORG-08-39EUDRACT-2008-006907-22EU-20933
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 9

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 6-month survival rate

  6 months

Secondary Outcomes (5)

• Progression-free survival

  6 months

• Overall response rate

  up to 6 months

• Clinical benefit

  6 months

• Safety and tolerability

  Throughout course of study

• Tumour biomarker analysis

  Currently ongoing

Study Arms (1)

Capecitabine and Lapatinib

EXPERIMENTAL

Drug: capecitabine; Drug: lapatinib ditosylate

Interventions

capecitabine DRUG

Capecitabine and Lapatinib

lapatinib ditosylate DRUG

Capecitabine and Lapatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (9)

Cork University Hospital

Cork, Ireland

Location

Mercy University Hospital

Cork, Ireland

Location

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

Dublin, 24, Ireland

Location

St. Vincent's University Hospital

Dublin, 4, Ireland

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

Mater Private Hospital

Dublin, 7, Ireland

Location

St. James's Hospital

Dublin, 8, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

University College Hospital

Galway, Ireland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Lapatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ray McDermott, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Last Updated: December 31, 2014

Record last verified: 2012-10

Locations

IE (9)