Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic Colorectal Cancer, Advanced Colorectal Cancer
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.
Interventions
DRUGTAS-102
TAS-102 Twice a day by mouth day 1-5 and 8-12
DRUGBevacizumab
Bevacizumab by intravenous infusion once every 14 days
Sponsors
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Progression-Free Survival | From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | TAS-102 and Bevacizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 4 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
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.
Time frame: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.
Population: The study was terminated early due to recruitment difficulties. 4 subjects were enrolled but no outcomes data was collected and no analysis was performed.