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