Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow enrollment
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lapatinib and Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lapatinib and Capecitabine
- description
- Treatment
- interventionNames
- Drug: Lapatinib and Capecitabine
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 24 months
- description
- Time of study entry to time of death
Secondary outcomes (3)
- measure
- Clinical Benefit Response
- timeFrame
- 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available