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Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

Primary Purpose

Pancreas Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Lapatinib and Capecitabine

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreas cancer, lapatinib, capecitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Georgetown University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lapatinib and Capecitabine

Arm Description

Treatment

Outcomes

Primary Outcome Measures

Overall Survival

Time of study entry to time of death

Secondary Outcome Measures

Clinical Benefit Response

number of participants who had stable disease or partial response or complete response per Response Evaluation Criteria In Solid Tumors. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Progression Free Survival

Time of study entry to cancer progression.

Adverse Events

Grade 3 or 4 toxicities

Full Information

NCT ID

NCT00881621

First Posted

April 13, 2009

Last Updated

January 17, 2017

Sponsor

Georgetown University

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00881621

Brief Title

Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

Official Title

Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Terminated

Why Stopped

slow enrollment

Study Start Date

August 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Georgetown University

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer

Keywords

Pancreas cancer, lapatinib, capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lapatinib and Capecitabine

Arm Type

Experimental

Arm Description

Treatment

Intervention Type

Drug

Intervention Name(s)

Lapatinib and Capecitabine

Other Intervention Name(s)

Tykerb, GW572016

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time of study entry to time of death

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Clinical Benefit Response

Description

Time Frame

3 months

Title

Progression Free Survival

Description

Time of study entry to cancer progression.

Time Frame

24 months

Title

Adverse Events

Description

Grade 3 or 4 toxicities

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruth He, MD, PhD

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown University Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

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