Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

NCT ID: NCT00881621

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-06-30

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.

Detailed Description

This is an open-label single-arm Phase II trial for patients with metastatic pancreatic cancer who have failed first line Gemcitabine-based therapy. Patients will be treated with a combination of Capecitabine and Lapatinib, a dual tyrosine-kinase inhibitor of EGFR and HER-2.

Conditions

Pancreas Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lapatinib and Capecitabine

Treatment

Group Type: EXPERIMENTAL

Lapatinib and Capecitabine

Intervention Type: 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

Interventions

Lapatinib and Capecitabine

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

Intervention Type: DRUG

Other Intervention Names

Tykerb; GW572016

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruth He, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Medical Center

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

Countries

United States

Other Identifiers

IND #103,981

Identifier Type: OTHER

Identifier Source: secondary_id

2008-437

Identifier Type: OTHER

Identifier Source: secondary_id

011438

Identifier Type: -

Identifier Source: org_study_id