Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer

NCT00107536 | Completed Phase 2 Results

• 5 other identifiers: NCI-2012-01464OSU 0447N01CM62207N01CM62201CDR0000420830
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well lapatinib ditosylate works in treating patients with unresectable liver or biliary tract cancer

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)

• Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST

  PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.

  Up to 3 years

Secondary Outcomes (6)

• Progression-free Survival

  up to 6 months

• Toxicity Profile Assessed Using NCI CTCAE Version 3.0

  Up to 3 years

• Median Overall Survival

  Up to 3 years

• Overall Survival

  up to 12.6 months

• Target-EGFR/EGFR-P Protein Expression

  Up to 3 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral lapatinib ditosylate 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

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

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of 1 of the following:
• Hepatocellular carcinoma (hepatoma)
• Child-Pugh classification score ≤ 7
• Biliary tract carcinoma
• Surgically unresectable disease
• Measurable disease
• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Fresh tissue or paraffin embedded tissue from tumor blocks available
• No ampulla of Vater tumors
• No known brain metastases
• Performance status - ECOG 0-1
• Performance status - Karnofsky 60-100%
• More than 12 weeks
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 75,000/mm\^3

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Peck J, Wei L, Zalupski M, O'Neil B, Villalona Calero M, Bekaii-Saab T. HER2/neu may not be an interesting target in biliary cancers: results of an early phase II study with lapatinib. Oncology. 2012;82(3):175-9. doi: 10.1159/000336488. Epub 2012 Mar 15.

  PMID: 22433475 BACKGROUND

• Bekaii-Saab T, Markowitz J, Prescott N, Sadee W, Heerema N, Wei L, Dai Z, Papp A, Campbell A, Culler K, Balint C, O'Neil B, Lee RM, Zalupski M, Dancey J, Chen H, Grever M, Eng C, Villalona-Calero M. A multi-institutional phase II study of the efficacy and tolerability of lapatinib in patients with advanced hepatocellular carcinomas. Clin Cancer Res. 2009 Sep 15;15(18):5895-901. doi: 10.1158/1078-0432.CCR-09-0465. Epub 2009 Sep 8.

  PMID: 19737952 RESULT

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: Tanio Bekaii-Saab, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Tanios.Bekaii-Saab@osumc.edu

614-293-9863

Study Officials

• Tanios Bekaii-Saab

  Ohio State University 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: April 5, 2005
• First Posted: April 6, 2005
• Study Start: October 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: April 29, 2015
• Results First Posted: April 29, 2015

Record last verified: 2015-03

Locations

US (1)