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

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ClinicalTrials.gov Identifier: NCT02654639
Recruitment Status : Terminated (Principal investigator left the institution)
First Posted : January 13, 2016
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Georgetown University

Study Description
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Brief Summary:
Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: TAS-102 Drug: Bevacizumab Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : February 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
 Drug: TAS-102
TAS-102 Twice a day by mouth day 1-5 and 8-12
Other Names:
  • Lonsurf
  • Avastin

Drug: Bevacizumab
Bevacizumab by intravenous infusion once every 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Length of Progression-Free Survival [ Time Frame: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years. ]
    Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654639


Locations
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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
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Principal Investigator: Mohamed Salem, MD Georgetown University
  Study Documents (Full-Text)

Documents provided by Georgetown University:
Study Protocol and Statistical Analysis Plan  [PDF] July 17, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02654639    
Other Study ID Numbers: 2015-0959
First Posted: January 13, 2016    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: April 2018
Keywords provided by Georgetown University:
Metastatic Colorectal Cancer
Advanced Colorectal Cancer
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors