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

Metastatic Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02654639
• Other study ID #: 2015-0959
• Status: Terminated
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2018
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• TAS-102
TAS-102 Twice a day by mouth day 1-5 and 8-12
• Bevacizumab
Bevacizumab by intravenous infusion once every 14 days

Locations

Country	Name	City	State
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.