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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• erlotinib hydrochloride — DRUG
  Given orally
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

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.

Key Dates

First listed

Jun 6, 2003

Start date

Mar 31, 2002

Status verified

Jun 2013

Primary completion

Nov 30, 2006

Study Design

Enrollment

78 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Arm I
  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.

Primary Outcome Measure

Proportion of patients who are progression-free at 24 weeks [ Time Frame: At 24 weeks ]

Locations (1)

Find similar trials in Rochester, MN