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

Primary Purpose

Metastatic Colorectal Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TAS-102

Bevacizumab

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Advanced Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Georgetown University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAS-102 and Bevacizumab

Arm Description

Oral TAS-102 and intravenous Bevacizumab.

Outcomes

Primary Outcome Measures

Length of Progression-Free Survival

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02654639

First Posted

January 8, 2016

Last Updated

July 11, 2018

Sponsor

Georgetown University

1. Study Identification

Unique Protocol Identification Number

NCT02654639

Brief Title

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

Acronym

ALEXANDRIA

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

Principal investigator left the institution

Study Start Date

February 2016 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer, Advanced Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAS-102 and Bevacizumab

Arm Type

Experimental

Arm Description

Oral TAS-102 and intravenous Bevacizumab.

Intervention Type

Drug

Intervention Name(s)

TAS-102

Other Intervention Name(s)

Lonsurf, Avastin

Intervention Description

TAS-102 Twice a day by mouth day 1-5 and 8-12

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab by intravenous infusion once every 14 days

Primary Outcome Measure Information:

Title

Length of Progression-Free Survival

Description

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.

Time Frame

From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed Salem, MD

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28712102

Citation

Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.

Results Reference

derived

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

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