A Phase II Study of GW572016 (Lapatanib) in Locally Advanced or Metastatic Hepato-Biliary Cancers
Overview
- Phase
- Phase 2
- Intervention
- lapatinib ditosylate
- Conditions
- Adult Primary Hepatocellular Carcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Response Rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description
PRIMARY OBJECTIVES: I. The goal of this study is to determine the objective response rate of GW572016 in patients with biliary cancer and hepatocellular cancer (HCC). SECONDARY OBJECTIVES: I. Determine the overall survival of patients entered onto study. II. Quantitative and qualitative toxicities of the patient population treated with GW572016. III. Determine the progression free survival of patients. IV. To perform molecular and pharmacogenomic correlative studies that will identify specific patient subsets that benefit from GW572016 therapy. OUTLINE: This is a multicenter study. Patients are stratified according to tumor site (biliary tree cancer \[includes ampullary, bile duct, and gall bladder cancer\] vs hepatocellular cancer). Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically or cytologically confirmed, surgically unresectable biliary cancer (gallbladder, ampullary, intra or extrahepatic bile duct) OR patients must have surgically unresectable HCC and who are not candidates for percutaneous ethanol injection or radio frequency ablation (RFA); patients must have histological or cytological confirmation of HCC
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan; if a patient has undergone TACE, ethanol or RFA ablation then new lesions need to be present in the liver, if there are no other sites of disease
- •Patients may have received prior therapy as follows:
- •No more than one prior chemotherapy regimen for metastatic or recurrent disease will be allowed; prior chemotherapy for earlier stage disease (neoadjuvant, adjuvant, or concurrent with radiation therapy) will be allowed in addition to prior chemotherapy for recurrent metastatic disease; TACE is considered one regimen; at least 3 weeks must have elapsed since prior therapy, and toxicities of therapy should have resolved to =\< Grade 1
- •Patients may have received prior radiation therapy; three weeks must have elapsed since the completion of prior radiation therapy and patients must have recovered from all toxicities; measurable disease must either be outside the previous radiation field, or progressing within a radiated field, or a new lesion must be present
- •There must be no plans for the patient to receive concurrent hormonal, biologic, or radiation therapy to measurable lesions
- •Patients who have had prior treatment with EGFR targeting therapies are ineligible
- •Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy
- •Life expectancy of greater than 12 weeks
- •ECOG performance status less than or equal to 2 (Karnofsky \>= 60%)
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: lapatinib ditosylate
Treatment (lapatinib ditosylate)
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Response Rate
Time Frame: Up to 5 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Secondary Outcomes
- Overall Survival(Up to 5 years)
- Disease Control Rate.(Up to 5 years)
- Progression-free Survival(Up to 5 years)