Gemcitabine Hydrochloride, Oxaliplatin, and Erlotinib Hydrochloride in Treating Patients With Advanced Biliary Tract Cancer, Pancreatic Cancer, Duodenal Cancer, or Ampullary Cancer - Full Text View

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	Laura W. Goff, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00987766

Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and oxaliplatin together with erlotinib hydrochloride may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with gemcitabine hydrochloride and oxaliplatin in treating patients with advanced biliary tract cancer, pancreatic cancer, duodenal cancer, or ampullary cancer.

Condition	Intervention	Phase
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Pancreatic Cancer Periampullary Adenocarcinoma Small Intestine Cancer	Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Drug: oxaliplatin Other: laboratory biomarker analysis	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase Ib Trial of Gemcitabine and Oxaliplatin (GEMOX) With Erlotinib in Patients With Advanced Biliary Tract Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Intestinal Cancer Liver Cancer Pancreatic Cancer

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:

Maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in combination with gemcitabine hydrochloride and oxaliplatin [ Time Frame: Completion of phase I ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Antitumor activity [ Time Frame: 30 days after completing treatment. ] [ Designated as safety issue: No ]
E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response [ Time Frame: 30 days after completing treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment:	22
Study Start Date:	November 2009
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Gemcitabine + Oxaliplatin + Erlotinib	Drug: erlotinib hydrochloride Taken daily by mouth for 6 days every other week. Drug: gemcitabine hydrochloride Given through a vein in the arm 1 time every other week. Drug: oxaliplatin Given through a vein in the arm 1 time every other week. Other: laboratory biomarker analysis Blood and tissue collection.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987766

Contacts

Contact: Vanderbilt-Ingram Cancer Center, Clinical Trials Program

800-811-8480

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program 800-811-8480
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Laura Goff, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laura W. Goff, Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:	NCT00987766 History of Changes
Other Study ID Numbers:	VICC-GI-0906, P30CA068485, VU-VICC-GI-0906, IRB# 090432
Study First Received:	September 30, 2009
Last Updated:	November 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:

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

Additional relevant MeSH terms:

Adenocarcinoma
Liver Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Intestinal Neoplasms
Biliary Tract Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms

Neoplasms by Site
Digestive System Diseases
Liver Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Duodenal Diseases
Intestinal Diseases
Ileal Diseases
Jejunal Diseases
Biliary Tract Diseases
Gallbladder Diseases
Bile Duct Diseases

ClinicalTrials.gov processed this record on February 09, 2012