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

This study has been completed.
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00626158
First received: February 14, 2008
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Biliary Cancer
Drug: gemcitabine
Drug: capecitabine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate (ORR) and disease control rate (DCR) in patients with measurable disease at baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Biomarker (CA19-9) response rate (decline by ≥ 50%) in patients with elevated CA19-9 (≥ 2x ULN) at baseline. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Time to tumor progression (TTP) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Frequency, type, and grade of adverse events using this combination in this patient population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: February 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gem/Cape Drug: gemcitabine
1000 mg/m2 IV day 1 of every cycle for 100 minutes (each cycle 14 days)
Other Name: gemzar
Drug: capecitabine
starting dose 1000 mg/m2 PO twice a day for days 1-7 of each cycle (each cycle 14 days)
Other Name: xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626158

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Utah
Huntsman Cancer Center, University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of California, San Francisco
National Comprehensive Cancer Network
Investigators
Principal Investigator: Andrew Ko, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00626158     History of Changes
Other Study ID Numbers: CC#074510
Study First Received: February 14, 2008
Last Updated: April 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
pancreatic cancer
biliary cancer
gemcitabine
capecitabine

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Pancreatic Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Capecitabine
Fluorouracil
Gemcitabine
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014