Trial record 1 of 1 for:    NCT01722162
Previous Study | Return to List | Next Study

Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01722162
First received: October 29, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

This randomized phase II trial studies how giving a drug called levocetirizine to patients with colorectal cancer affects their tumor response to capecitabine and bevacizumab. Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels that feed them. Patients with colorectal cancer can develop a resistance to the effects of bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving bevacizumab, capecitabine, and levocetirizine dihydrochloride together may be an effective treatment for refractory colorectal cancer.


Condition Intervention Phase
Colorectal Neoplasms
Drug: Bevacizumab
Drug: Capecitabine
Drug: Levocetirizine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Levocetirizine in Combination With Capecitabine + Bevacizumab to Overcome Resistance to Anti-angiogenic Therapy in Patients With Refractory Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • progression free survival [ Time Frame: up to 5 months ] [ Designated as safety issue: No ]
    Time from start of treatment to the time of progression or death, whichever occurs first. Cox proportional hazards models will be used to estimate median PFS with a 95% confidence interval. A comparison will be made to a historic median PFS of 1.7 months for this patient population.


Secondary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0


Estimated Enrollment: 36
Study Start Date: April 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: (start levocetirizine after bevacizumab/capecitabine)

Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.

Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.

Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2.

Drug: Bevacizumab
Other Name: Avastin®
Drug: Capecitabine
Other Name: Xeloda®
Drug: Levocetirizine
Other Name: Xyzal
Experimental: Arm B: (start levocetirizine before bevacizumab/capecitabine)

Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.

Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.

Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2.

Drug: Bevacizumab
Other Name: Avastin®
Drug: Capecitabine
Other Name: Xeloda®
Drug: Levocetirizine
Other Name: Xyzal

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have histologically or cytologically confirmed refractory colorectal cancer (CRC).
  • Patient must have measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, as ≥20 mm by chest x-ray, or ≥10 mm with calipers by clinical exam.
  • Patient must have documented progressive disease within 3 months of his/her most recent cycle of chemotherapy.
  • Patient must be refractory to or intolerant of prior therapy with a fluoropyrimidine, oxaliplatin, irinotecan, and/or anti-angiogenic therapy. Patients with K-RAS wild type tumors must have received an epidermal growth factor receptor (EGFR) inhibitor such as cetuximab or panitumumab.
  • Patient must be ≥ 18 years of age.
  • Patient must have an ECOG performance status ≤ 2
  • Patient must have normal bone marrow and organ function as defined below:

    • Absolute neutrophil count ≥ 1,500/mcl
    • Platelets ≥ 100,000/mcl
    • Total bilirubin ≤ 2.0 x IULN
    • AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
    • Patients must have adequate renal function prior to chemotherapy defined as serum creatinine ≤ 2.0 mg/dl OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above 2.0
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) 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 must inform her treating physician immediately.
  • Patient must be able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

  • Patient must not have a history of other malignancy ≤ 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
  • Patient must not be receiving any other investigational agents.
  • Patient must not have known active brain metastases. Patients with previously treated brain metastases are eligible. Patients with known brain active metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Patient must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to levocetirizine, capecitabine, bevacizumab, or other agents used in the study.
  • Patient must not have known dihydropyrimidine dehydrogenase (DPD) deficiency or severe renal impairment (creatinine clearance below 30 mL/min by Cockcroft and Gault formula) as this would prelude use of capecitabine.
  • Patient must not have known proteinuria ≥ 500mg/24 hours.
  • Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not be pregnant and/or breastfeeding. Patient must have a negative urine pregnancy test within seven days of study entry.
  • Patient must not be known to be HIV-positive on combination antiretroviral because of the potential for pharmacokinetic interactions with levocetirizine, capecitabine, and bevacizumab. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  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: NCT01722162

Contacts
Contact: A. Craig Lockhart, M.D. 314-362-5740 alockhar@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Craig Lockhart, M.D.         
Sub-Investigator: Joel Picus, M.D.         
Sub-Investigator: Timothy Pluard, M.D.         
Sub-Investigator: Caron Rigden, M.D.         
Sub-Investigator: Anna Roshal, M.D.         
Sub-Investigator: Steven Sorscher, M.D.         
Sub-Investigator: Rama Suresh, M.D.         
Sub-Investigator: Benjamin Tan, M.D.         
Sub-Investigator: Andrea Wang-Gillam, M.D., Ph.D.         
Sub-Investigator: Monica Desai, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: A. Craig Lockhart, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01722162     History of Changes
Other Study ID Numbers: 201303043
Study First Received: October 29, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Fluorouracil
Bevacizumab
Levocetirizine
Cetirizine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on July 28, 2014