- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00881621
Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer
Phase II Study of Lapatinib and Capecitabine in 2nd Line Treatment of Locally Advanced/Metastatic Pancreatic Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20007
- Georgetown University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lapatinib and Capecitabine
Treatment
|
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 24 months
|
Time of study entry to time of death
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Benefit Response
Time Frame: 3 months
|
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. |
3 months
|
Progression Free Survival
Time Frame: 24 months
|
Time of study entry to cancer progression.
|
24 months
|
Adverse Events
Time Frame: 2 years
|
Grade 3 or 4 toxicities
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruth He, MD, PhD, Georgetown University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Capecitabine
- Lapatinib
Other Study ID Numbers
- 011438
- IND #103,981 (Other Identifier: FDA)
- 2008-437 (Other Identifier: IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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