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Trial record 2 of 24 for:    tas-102

Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer (ALEXANDRIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Georgetown University
Sponsor:
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT02654639
First received: January 8, 2016
Last updated: August 17, 2016
Last verified: August 2016
  Purpose
Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: TAS-102 and Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-center, Phase 2 Study of Switch Maintenance With TAS-102 Plus Bevacizumab Following Oxaliplatin or Irinotecan-Based Fluoropyrimidine-Containing Induction Chemotherapy in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: February 2016
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
Drug: TAS-102 and Bevacizumab
TAS-102 Twice a day by mouth day 1-5 and 8-12 and Bevacizumab by intravenous infusion once every 14 days
Other Names:
  • Lonsurf
  • Avastin

Detailed Description:

Study Drug:

TAS-102 (trifluridine and tipiracil hydrocholoride) and bevacizumab

Dosing Details:

Starting dose of TAS-102 is 35 mg/m2 administered orally twice daily, after meals, for 5 days a week with 2 days rest for 14 days, followed by 14 days rest (1 treatment cycle).

Bevacizumab 5 mg/kg intravenously every 14 days. The treatment cycle repeats every 28 days. Patients may take TAS-102 plus bevacizumab until they exhibit progression of disease, withdraw consent, or experience unacceptable toxicity.This is a single arm study. All patients receive the same study treatment.

  Eligibility

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

Inclusion criteria:

  • Written informed consent
  • Histologically proven, unresectable, evaluable metastatic colorectal cancer
  • 16 to 20 weeks of first-line therapy with oxaliplatin, and/or irinotecan-based flourorpyrimidine-containing chemotherapy plus Bevacizumab
  • Patients must have stable disease (or better) during the initial induction chemotherapy with first-line chemotherapy.
  • No progressive disease at the time of initiation of maintenance therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
  • Adequate organ and marrow function
  • Women of child-bearing potential and men must agree to avoid pregnancy
  • Patient must start maintenance therapy at least 14 days after the last administered induction chemotherapy but no later than 30 days.

Exclusion Criteria

  • Patients whose tumors have progressed on first-line treatment
  • Patients with active concurrent malignancy, other than superficial, non-invasive squamous cell carcinoma of the skin or uterine cervix, within the past three years.
  • Women who are pregnant or lactating
  • Unstable heart disease
  • Uncontrolled active infection requiring antibiotics within one week prior to first dose.
  • Patients with active CNS malignancy.
  • Persistent protein in the urine
  • Patients with bowel obstruction or uncontrolled vomiting.
  • Patients with serious psychiatric or medical conditions that could interfere with treatment.
  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: NCT02654639

Contacts
Contact: Karen Vogel, RN 202-687-6974 kd252@georgetown.edu
Contact: Holly DiFebo, BSN 202-687-5760 hmd27@georgetown.edu

Locations
United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: Mohamed Salem, MD Georgetown University
  More Information

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02654639     History of Changes
Other Study ID Numbers: 2015-0959 
Study First Received: January 8, 2016
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
Metastatic Colorectal Cancer
Advanced Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Trifluridine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 07, 2016