Gemcitabine And Capecitabine To Treat Patients With Advanced Pancreatic And Biliary Cancers

Study Overview

Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers

The purpose of this study is to find out what effects gemcitabine plus capecitabine has on patients with pancreatic or biliary cancer, and to determine the optimal dose that can be given safely of these two drugs together (called the maximum tolerated dose). Gemcitabine and capecitabine are two chemotherapy drugs used to treat pancreatic and biliary cancer. These two drugs used together are considered an acceptable standard of care for pancreatic and biliary cancers. However, in this study the dose and dosing schedule will be changed, in the hopes that the drugs will have more effect with fewer side effects than when given in the standard way.

N/A

Pancreatic Cancer
Biliary Cancer

DRUG: gemcitabine
DRUG: capecitabine

CC#074510

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-02-14	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-04-03
First Submitted that Met QC Criteria 2008-02-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-04-04
First Posted (ESTIMATED) 2008-02-29	Results First Posted N/A	Last Verified 2012-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Gem/Cape	DRUG: gemcitabine 1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days) DRUG: capecitabine starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Gem/Cape

DRUG: gemcitabine

1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days)

DRUG: capecitabine

starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)

Primary Outcome Measures	Measure Description	Time Frame
To establish the maximum tolerated dose of fixed-dose rate gemcitabine plus capecitabine given by biweekly administration in patients with advanced pancreatic and biliary tract malignancies.		2 years

Secondary Outcome Measures	Measure Description	Time Frame
Objective response rate (ORR) and disease control rate (DCR) in patients with measurable disease at baseline		2 years
Biomarker (CA19-9) response rate (decline by ≥ 50%) in patients with elevated CA19-9 (≥ 2x ULN) at baseline.		2 years
Time to tumor progression (TTP)		2 years
Overall survival		2 years
Frequency, type, and grade of adverse events using this combination in this patient population		2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically-confirmed pancreatic adenocarcinoma or biliary tract carcinoma (cholangiocarcinoma or gallbladder cancer)
Disease must not be amenable to surgical resection. Patients with either locally advanced or metastatic disease are eligible
No prior systemic therapy for their diagnosis
ECOG performance score of 0-1
Evidence of either or both of the following:

Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
Adequate bone marrow function:

Adequate hepatic function:

Adequate renal function as determined by either:

Ability to swallow oral medications
Ability to understand the nature of this study protocol and give written informed consent
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Any prior systemic or investigational therapy for metastatic or locally advanced pancreatic cancer or biliary cancer. Systemic therapy administered alone or in combination with radiation in the adjuvant setting is permissible as long as it was completed > 6 months prior to the time of study enrollment.
Inability to comply with study and/or follow-up procedures.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study.
Presence of central nervous system or brain metastases.
Pregnancy (positive pregnancy test) or lactation.
Prior malignancy except for adequately treated basal 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 form of cancer from which the patient has been disease-free for 5 years.
Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Known, existing uncontrolled coagulopathy.
Major surgery within 4 weeks of the start of study treatment, without complete recovery.
Concurrent/pre-existing use of coumadin.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Comprehensive Cancer Network

Investigators

PRINCIPAL_INVESTIGATOR: Andrew Ko, MD, University of California, San Francisco

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record