Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
Stopped early · Phase 2
Conditions studied: Metastatic Colorectal Cancer
In brief
Phase II study of TAS-102 plus bevacizumab switch maintenance therapy in patients with mCRC
Key facts
- Study ID
- NCT02654639
- Run by
- Georgetown University
- People needed
- 4
- Starts
- 2016-02-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2018-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Georgetown University — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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