Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

NCT00881621 | Terminated Phase 2 Results DMC

• 3 other identifiers: 011438IND #103,9812008-437
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 worse after first-line chemotherapy. The purpose of this study is to see if the drugs, Capecitabine and Lapatinib (two chemotherapy agents), prolong survival and improve quality of life as compared to supportive care alone. Lapatinib in combination with a drug called capecitabine, has been approved by the Food and Drug Administration (FDA) for the treatment of metastatic breast cancer. It has not yet been approved to treat this type of cancer. Both of these drugs are pills. This research is being done because it is not known if the combination of Capecitabine and Lapatinib is better than supportive care alone for pancreatic cancer.

Conditions

Pancreas Cancer

Keywords

Pancreas cancer; lapatinib; capecitabine

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time of study entry to time of death

  24 months

Secondary Outcomes (3)

• Clinical Benefit Response

  3 months

• Progression Free Survival

  24 months

• Adverse Events

  2 years

Study Arms (1)

Lapatinib and Capecitabine

EXPERIMENTAL

Treatment

Drug: Lapatinib and Capecitabine

Interventions

Lapatinib and Capecitabine DRUG

Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles

Also known as: Tykerb, GW572016

Lapatinib and Capecitabine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Lapatinib; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Aiwu Ruth He
• Organization: Georgetown University

arh29@georgetown.edu

202-444-8642

Study Officials

• Ruth He, MD, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: March 3, 2025
• Results First Posted: March 6, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)