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:	National Cancer Institute (NCI)
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:	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 National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Antitumor activity [ Designated as safety issue: No ]
E-cadherin, vimentin, fibronectin, amphiregulin, and Kras status in the tumors and their relationship to response [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	November 2009
Estimated Primary Completion Date:	January 2016 (Final data collection date for primary outcome measure)

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

DISEASE CHARACTERISTICS:

Biopsy-confirmed diagnosis of one of the following:
- Biliary tract adenocarcinoma
- Pancreatic cancer
- Duodenal cancer
- Ampullary cancer (cytology acceptable)
Advanced disease
Measurable tumor by imaging examination
No CNS metastases

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
ANC > 1,500/mm^3
Platelet count > 100,000/mm^3
Bilirubin < 2.5 times normal
Serum creatinine < 1.5 times normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
No other prior malignancy except for any of the following:
- Adequately treated basal cell or squamous cell skin cancer
- In situ cervical cancer
- Adequately treated stage I or II cancer for which the patient is currently in complete remission
- Any other cancer for which the patient has been disease-free for 5 years
No psychiatric illness that would prevent understanding the nature of the investigational therapy and complying with study requirements
No concurrent medical condition that, in the judgement of the investigator, would make the patient an inappropriate candidate for study enrollment

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or EGF receptor inhibitor therapy

Contacts and Locations

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

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Laura W Goff 615-936-0059
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 W. 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

No publications provided

Responsible Party:	Vanderbilt-Ingram Cancer Center ( Laura Williams Goff )
Study ID Numbers:	CDR0000655893, VU-VICC-GI-0906, IRB# 090432
Study First Received:	September 30, 2009
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00987766 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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:

Antimetabolites
Gallbladder Diseases
Anti-Infective Agents
Liver Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Pancreatic Neoplasms
Physiological Effects of Drugs
Protein Kinase Inhibitors
Ileal Diseases
Duodenal Neoplasms
Liver Neoplasms

Oxaliplatin
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Therapeutic Uses
Biliary Tract Diseases
Gemcitabine
Duodenal Diseases
Endocrine Gland Neoplasms
Erlotinib
Jejunal Neoplasms
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Digestive System Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 08, 2010