Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery

NCT00101036 | Completed Phase 2 Results

• 5 other identifiers: NCI-2012-03065PHII-536674N01CM62201N01CM62209
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Recurrent Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer; Unresectable Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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

  Up to 5 years

Secondary Outcomes (3)

• Overall Survival

  Up to 5 years

• Progression-free Survival

  Up to 5 years

• Disease Control Rate.

  Up to 5 years

Study Arms (1)

Treatment (lapatinib ditosylate)

EXPERIMENTAL

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: lapatinib ditosylate; Other: laboratory biomarker analysis

Interventions

lapatinib ditosylate DRUG

Given PO

Also known as: GSK572016, GW-572016, GW2016, Lapatinib, Tykerb

Treatment (lapatinib ditosylate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (lapatinib ditosylate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)
• Patients who have scores that fall into Childs B or C groups are excluded
• Patients must have organ and marrow function as defined below:
• Leukocytes \>= 3000/mcL
• Absolute neutrophil count \>= 1,500/mcL
• Platelets \>= 75,000/mcL

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Lapatinib; N-(3-chloro-4-((3-fluorobenzyl)oxy)phenyl-6-(5-((methylsulfonyl)ethyl)aminomethyl)-2-furyl)-4-quinazolinamine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: DCC Project Administrator
• Organization: California Cancer Consortium

CCCP@coh.org

626-256-4673

Study Officials

• Ramesh Ramanathan

  UC Davis Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: November 1, 2004
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 20, 2018
• Results First Posted: January 5, 2015

Record last verified: 2018-03

Locations

US (1)