Clinical trial NCT02654639: Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic Colorectal Cancer
Advanced Colorectal Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Length of Progression-Free Survival
timeFrame: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Mohamed Salem, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.