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

NCT01007552 | Completed Phase 2 Results DMC

• 1 other identifier: I 150509
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the proposed therapy for patients with advanced gallbladder or biliary cancers.

Conditions

Cholangiocarcinoma

Keywords

Biliary Duct Cancer; Cancer of the Gallbladder; Adenocarcinoma of the Gall Bladder; Adenocarcinoma of the Biliary Ducts; Cholangiocarcinoma; Extrahepatic cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

Secondary Outcomes (6)

• Estimate the Proportion of Patients With Clinical Response

  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

• Assess the Toxicity of the Regimen.

  up to 5 years

• Assess the Change in the Quality of Life Among Patients Using the FACT-Hep (Version 4) for Hepatobiliary Cancers.

  Baseline, Day 22 and Day 43

• Assess Overall Survival (OS)

  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

  baseline, day 22 and day 43

Study Arms (1)

Gemcitabine, Capecitabine and Bevacizumab

EXPERIMENTAL

Estimate the toxicity of the regimen, and estimate the quality of life (QOL).

Drug: Gemcitabine, Capecitabine and Bevacizumab

Interventions

Gemcitabine, Capecitabine and Bevacizumab DRUG

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.

Gemcitabine, Capecitabine and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma; Gallbladder Neoplasms

Interventions

Gemcitabine; Capecitabine; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

groman@appliedstats.com

716-845-2300

Study Officials

• Renuka Iyer, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 4, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (2)