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A Study of Gemcitabine, Capecitabine and Bevacizumab to Treat Cancer of the Gall Bladder or Bile Ducts

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01007552
First received: November 2, 2009
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.

Condition Intervention Phase
Cholangiocarcinoma
Drug: Gemcitabine, Capecitabine and Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Gemcitabine, Capecitabine and Bevacizumab for Locally Advanced or Metastatic Adenocarcinoma of the Gall Bladder or Biliary Ducts.

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • The Primary Objective of This Study is to Assess Progression Free Survival (PFS) With Proposed Therapy for Patients With Locally Advanced or Metastatic Gallbladder and Biliary Cancers. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]
    Progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0). Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Note: Lesions are either measurable or non-measurable using the criteria provided below. The term "evaluable" in reference to measurability will not be used because it does not provide additional meaning or accuracy.


Secondary Outcome Measures:
  • Estimate the Proportion of Patients With Clinical Response [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  • Assess the Toxicity of the Regimen. [ Time Frame: up to 5 years ]
    Number of patients with Serious Adverse Events. Please refer to the adverse event reporting for more detail.

  • Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers. [ Time Frame: Baseline, Day 22 and Day 43 ]

    We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores of the reflect better quality of life.

    For a Detailed description see:

    Nancy Heffernan, David Cella, Kimberly Webster, Linda Odom, Mary Martone, Steven Passik, Marilyn Bookbinder, Yuman Fong, William Jarnagin, and Leslie Blumgart: Measuring Health-Related Quality of Life in Patients With Hepatobiliary Cancers: The Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire. Journal of Clinical Oncology, Vol 20, No 9 (May 1), 2002: pp 2229-2239.

    No subscales were analyzed.


  • Assess Overall Survival (OS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years ]
  • Circulating Tumor Cells (CTC) Will be Assessed at Baseline, Day 22 and Day 43 [ Time Frame: baseline, day 22 and day 43 ]
    Mean number of CTCs in 7.5 ml of whole blood

  • Collect Samples at Baseline, Day 8 and Day 43 for Future Biomarker Studies and Development of Profiles of Responders to Anti-VEGF Therapy (Optional) [ Time Frame: Baseline, day 8 and day 43 ]
    This was a tissue banking end point of sample collection for future studies. No analysis was completed.


Enrollment: 50
Study Start Date: December 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine, Capecitabine and Bevacizumab
Estimate the toxicity of the regimen, and estimate the quality of life (QOL).
Drug: Gemcitabine, Capecitabine and Bevacizumab
Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days.

Detailed Description:
The primary objective of this study is to assess progression free survival with proposed therapy for patients with locally advanced or metastatic adenocarcinoma of the gallbladder or biliary ducts.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed gallbladder or biliary tract adenocarcinoma that is unresectable or metastatic, or metastatic adenocarcinoma which is radiologically confirmed to be of gallbladder or biliary origin. No prior systemic therapy for metastatic disease. Prior adjuvant therapy is permitted if completed over 6months ago.
  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of bevacizumab in combination with gemcitabine in patients over 18 years of age, children are excluded from this study, but will be eligible for future pediatric phase 1 combination trials.
  • ECOG performance status 0 or 1.
  • Life expectancy > 3 months.
  • Patients must have normal organ and marrow function as defined below:

    • leukocytes ≥ 3,000/microL
    • absolute neutrophil count ≥ 1,500/microL
    • platelets ≥ 1OO,OOO/microL
    • total bilirubin ≤ 2 mg/dl
    • AST or ALT ≤ 5 times upper limit of normal (UNL) for subjects with documented liver metastases; ≤ 2.5 times UNL for subjects without evidence of liver metastases.
    • creatinine < 1.5 mg/dL or 24 hour urine creatinine clearance > 50 ml/min.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Signed, written informed consent document.
  • Patient must have measurable disease

Exclusion Criteria:

  • Subjects meeting any of the following criteria are ineligible for study entry:
  • Compromised renal or hepatic function.
  • Screening clinical laboratory values INR ≥ 1.5 (except those subjects who are receiving full-dose warfarin)
  • Hemoglobin < 9 gm/dL (may be transfused or receive epoetin alfa (e.g., Epogen@) to maintain or exceed this level).
  • Bevacizumab risk factors: History of serious systemic disease, including uncontrolled hypertension (blood pressure of greater than 160/110 mmHg on medication), prior history of hypertensive crisis or hypertensive encephalopathy, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease (Grade II or greater).
  • Presence of central nervous system or brain metastases.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study; fine needle aspirations or core biopsies within 7 days prior to Day O.
  • Pregnancy (positive pregnancy test) or lactation.
  • 24 hour urine creatinine clearance < 50 ml/min or urine protein/creatinine ratio greater than or equal to 1.0 at screening.
  • Serious, nonhealing wound, ulcer, or bone fracture.
  • Evidence of bleeding diathesis or coagu1opathy.
  • Recent (less than or equal to six months) arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular accident (CVA), unstable angina, or myocardial infarction (MI).
  • Inability to comply with study and/or follow-up procedures.
  • Patients with known duodenal or gastric wall involvement should be excluded.
  • Patients with suspected involvement of stomach or duodenum should have screening endoscopies to exclude the same prior to therapy.
  • Patients with esophageal or gastric varices.
  • Patients with recent hemoptysis (within 1 week).
  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: NCT01007552

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Roswell Park Cancer Institute
Genentech, Inc.
Investigators
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01007552     History of Changes
Other Study ID Numbers: I 150509
Study First Received: November 2, 2009
Results First Received: October 24, 2016
Last Updated: February 9, 2017

Keywords provided by Roswell Park Cancer Institute:
Biliary Duct Cancer
Cancer of the Gallbladder
Adenocarcinoma of the Gall Bladder
Adenocarcinoma of the Biliary Ducts
Cholangiocarcinoma
Extrahepatic cholangiocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Cholangiocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Capecitabine
Bevacizumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2017