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

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Brief Title

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

Official Title

A Phase I Study, With Expanded Cohort, of Biweekly Fixed-dose Rate Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic and Biliary Carcinomas

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 Objective response rate (ORR) and disease control rate (DCR) in patients with measurable disease at baseline

Condition

Pancreatic Cancer

Intervention

gemcitabine

Study Arms / Comparison Groups

 Gem/Cape
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

45

Start Date

February 2008

Completion Date

December 2010

Primary Completion Date

December 2010

Eligibility Criteria

        Inclusion Criteria:

          -  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:

               1. RECIST-defined measurable disease (lesions that can be accurately measured in at
                  least one dimension with the longest diameter ≥ 20mm using conventional
                  techniques or ≥10 mm with spiral CT scan)

               2. An elevated serum CA19-9 at baseline ( ≥ 2X ULN)

          -  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:

               1. ANC ≥ 1500/uL

               2. platelet count ≥ 100,000/uL

               3. hemoglobin ≥ 9.0 g/dL

          -  Adequate hepatic function:

               1. Total bilirubin ≤ 1.5 X ULN

               2. AST (SGOT) ≤ 2.5 X ULN

               3. ALT (SGPT) ≤ 2.5 X ULN

          -  Adequate renal function as determined by either:

               1. Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated
                  creatinine clearance, Cockroft-Gault equation will be used)

               2. Serum creatinine ≤ 1.5 X ULN

          -  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.

        Exclusion Criteria:

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Andrew Ko, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00626158

Organization ID

CC#074510


Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco

Collaborators

 National Comprehensive Cancer Network

Study Sponsor

Andrew Ko, MD, Principal Investigator, University of California, San Francisco


Verification Date

April 2012