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Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Liver Cancer, Pancreatic Cancer, Periampullary Adenocarcinoma, Small Intestine Cancer

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Trial Information

Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.


OBJECTIVES:

Primary

- To determine the maximum tolerated dose and the recommended phase II dose of erlotinib
hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin in patients
with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary
cancer.

Secondary

- To describe any antitumor activity associated with this treatment regimen when given
during the dose-escalation and expanded-cohort portions of this study.

- To evaluate e-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the
tumors and assess their relationship to response.

OUTLINE: This is a multicenter, dose-escalation study of erlotinib hydrochloride.

Patients receive gemcitabine hydrochloride IV on day 1, oxaliplatin IV over 2 hours on day
2, and oral erlotinib hydrochloride once daily on days 3-8. Courses repeat every 2 weeks in
the absence of disease progression or unacceptable toxicity.

Tumor tissue samples are collected for biomarker and other analysis.

After completion of study treatment, patients are followed up for 30 days.


Inclusion Criteria:



- Only advanced carcinomas defined as unresectable or metastatic that are
histologically or cytologically confirmed to be biliary tract, pancreas, duodenal, or
ampullary carcinomas will be included.

- Dose-escalation: Patients > 18 years of age with biopsy-confirmed advanced biliary
tract adenocarcinoma, pancreas cancer, duodenal cancer, or ampullary cancer

- MTD expansion cohort: Patients > 18 years of age with biopsy-confirmed advanced
biliary tract adenocarcinoma only.

- No prior chemotherapy or prior EGF receptor inhibitor therapy

- Measurable tumor by imaging examination

- Performance status (PS) 0-2 on the ECOG performance scale

- Have pretreatment bilirubin<2.5x upper limit of normal (ULN), serum creatinine<1.5x
ULN, AST and ALT <2.5xULN or in the presence of liver metastasis <5xULN,
neutrophils>1500, platelets>100K, hemoglobin >9 g/dL

- Patients - both males and females - with reproductive potential (ie, menopausal for
less than 1 year and not surgically sterilized) must practice effective contraceptive
measures throughout the study. Women of childbearing potential must provide a
negative pregnancy test (serum or urine) within 14 days prior to registration.

- Have the ability to understand the requirements of the study and provide informed
consent

Exclusion Criteria:

- CNS metastases

- Uncontrolled infection

- Pregnant or nursing women may not participate.

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years.

- Psychiatric illness that would prevent understanding the nature of the
investigational therapy and complying with protocol requirements

- Patients with > grade 2 neuropathy

- Patients with > grade 2 uncontrolled nausea and vomiting despite antiemetics

- Any concurrent medical condition that, in the judgment of the investigator, would
make the patient an inappropriate candidate for study enrollment

- Prior chemotherapy or EGFR inhibitor

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Laura Goff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC GI 0906

NCT ID:

NCT00987766

Start Date:

November 2009

Completion Date:

July 2014

Related Keywords:

  • Extrahepatic Bile Duct Cancer
  • Gallbladder Cancer
  • Liver Cancer
  • Pancreatic Cancer
  • Periampullary Adenocarcinoma
  • Small Intestine Cancer
  • advanced adult primary liver cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • periampullary adenocarcinoma
  • small intestine adenocarcinoma
  • adenocarcinoma of the extrahepatic bile duct
  • adenocarcinoma of the gallbladder
  • unresectable extrahepatic bile duct cancer
  • unresectable gallbladder cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Liver Neoplasms
  • Pancreatic Neoplasms
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Intestinal Neoplasms
  • Biliary Tract Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064