Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
NCT ID: NCT02654639
Last Updated: 2018-08-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
4 participants
INTERVENTIONAL
2016-02-29
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
TAS-102
TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab
Bevacizumab by intravenous infusion once every 14 days
Interventions
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TAS-102
TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab
Bevacizumab by intravenous infusion once every 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Georgetown University
OTHER
Responsible Party
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Principal Investigators
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Mohamed Salem, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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Georgetown University
Washington D.C., District of Columbia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-0959
Identifier Type: -
Identifier Source: org_study_id
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