Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer

NCT00033462 | Completed Phase 2

• 4 other identifiers: NCI-2012-02797MC01525429N01CM17104
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.

Conditions

Adult Primary Cholangiocellular Carcinoma; Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Cholangiocarcinoma of the Extrahepatic Bile Duct; Cholangiocarcinoma of the Gallbladder; 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 who are progression-free at 24 weeks

  Confidence intervals for the true PFR will be calculated using the methods of Duffy-Santner.

  At 24 weeks

Secondary Outcomes (5)

• Objective response, defined by the RECIST criteria in terms of tumor/lesion size and change

  Up to 3 years

• Overall survival

  Time from registration to death due to any cause, assessed up to 3 years

• Time to disease progression

  Time from registration to documentation of disease progression, assessed up to 3 years

• EGFR protein levels

  Baseline

• Overall response rate in EGFR positive patients

  Up to 3 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

Interventions

erlotinib hydrochloride DRUG

Given orally

Also known as: CP-358,774, erlotinib, OSI-774

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 or cytologically confirmed hepatocellular carcinoma (HCC) or biliary carcinoma that is surgically unresectable; exception: for surgically unresectable HCC, a hypervascular mass on CT and an AFP \> 100ng/mL will suffice as noninvasive diagnostic criteria
• Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm
• Absolute neutrophil count (ANC) ≥ 1500/mm3
• PLT ≥ 75,000/mm3
• Total bilirubin ≤ 2 x upper normal limits (UNL)
• Serum AST ≤ 3 x UNL
• Serum ALT ≤ 3 x UNL
• Serum creatinine ≤ 2 mg/dL
• Serum albumin ≥ 2.5 g/dL
• Patients not receiving anticoagulation: INR ≤ 1.5
• ECOG performance status (PS) 0, 1, or 2
• Estimated life expectancy ≥ 3 months
• Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide written informed consent
• HCC Patients Only: Child-Pugh classification of A or B
• For patients having prior cryotherapy, radiofrequency ablation, ethanol injection, or photodynamic therapy, the following criteria must be met:

You may not qualify if:

• Ampulla of Vater tumors
• Any of the following as this regimen may be harmful to a developing fetus or nursing child:
• Pregnant women
• Breastfeeding women
• Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.)
• NOTE: The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown
• Any of the following:
• \> 1 prior systemic anticancer therapy; Note: Chemoembolization will be considered as one prior chemotherapeutic regimen.
• Prior EGFR targeting therapy
• Nitrosoureas or mitomycin C ≤6 weeks prior to study entry
• Other chemotherapy ≤4 weeks prior to study entry
• Immunotherapy ≤ 4 weeks prior to study entry
• Biologic therapy ≤ 4 weeks prior to study entry
• Radiation therapy ≤ 4 weeks prior to study entry
• Prior cryotherapy, radiofrequency ablation, ethanol injection or photodynamic therapy ≤6 weeks prior to study entry

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bile Duct Neoplasms; Gallbladder Neoplasms

Interventions

Erlotinib Hydrochloride

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

Study Officials

• Philip Philip

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

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 9, 2002
• First Posted: June 6, 2003
• Study Start: March 1, 2002
• Primary Completion: November 1, 2006
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)