NCT03279289
Completed
Phase 2
Randomised, Multicentre, Phase II Pilot Study to Assess the Efficacy and Safety of Treatment With FOLFIRI-aflibercept Compared to Initial Treatment With FOLFIRI-aflibercept (for 6 Cycles) Followed by Maintenance With 5FU-aflibercept, in an Elderly Population With Metastatic Colorectal Cancer (mCRC) After Failure of an Oxaliplatin-based Regimen
Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 site in 1 country170 target enrollmentOctober 25, 2017
ConditionsMetastatic Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Aflibercept
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of treatment with FOLFIRI-aflibercept compared to initial treatment with FOLFIRI-aflibercept (for 6 cycles) followed by maintenance with 5FU-aflibercept, in an elderly population with metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-based regimen
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed and dated informed consent, and willing and able to comply with protocol requirements,
- •Histologically proven adenocarcinoma of the colon and/or rectum,
- •Existence of at least one measurable unidimensional lesion using CT or MRI based on the RECIST criteria, version 1.1
- •Patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed after a first line oxaliplatin-containing regimen for metastatic disease.
- •Age ≥70 years
- •World Health Organization (WHO) Performance status (PS) 0-2,
- •Hematological status: neutrophils (ANC) ≥1.5x109 /L; platelets ≥100x109 /L; haemoglobin ≥9 g/dL
- •Adequate renal function: Creatinine clearance ≥50 mL/min as calculated using the Cockcroft-Gault equation.
- •Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alkaline phosphatase (ALP) \<5xULN
- •Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour.
Exclusion Criteria
- •Uncontrolled hypercalcemia,
- •Pre-existing permanent neuropathy (NCI grade \>2)
- •Uncontrolled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
- •Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
- •Treatment with any other investigational medicinal product within 28 days prior to study entry.
- •Other serious and uncontrolled non-malignant disease,
- •History or evidence upon physical examination of CNS metastasis unless adequately treated (e.g. non irradiated CNS metastasis, seizure not controlled with standard medical therapy),
- •Patients classified as fragile or delicate according to the following criteria:
- •Dependence in one or more activities of daily living according to the Katz Index of Independence in Activities of Daily Living (ADL) scale
- •Three or more comorbidities when assessing the presence of the following processes: congestive heart failure; heart valve disease; coronary artery disease; chronic (obstructive or restrictive) pulmonary disease; cerebrovascular disease; peripheral neuropathy, chronic kidney failure; hypertension; diabetes; concomitant cancers; collagen vascular disease; chronic liver disease; and disabling arthritis
Arms & Interventions
Group A
INDUCTION PHASE: 6 cycles of FOLFIRI + aflibercept MAINTENANCE PHASE: 5FU/LV + aflibercept
Intervention: Aflibercept
Group A
INDUCTION PHASE: 6 cycles of FOLFIRI + aflibercept MAINTENANCE PHASE: 5FU/LV + aflibercept
Intervention: Irinotecan
Group A
INDUCTION PHASE: 6 cycles of FOLFIRI + aflibercept MAINTENANCE PHASE: 5FU/LV + aflibercept
Intervention: folinic acid (dl racemic)
Group A
INDUCTION PHASE: 6 cycles of FOLFIRI + aflibercept MAINTENANCE PHASE: 5FU/LV + aflibercept
Intervention: 5Fluorouracil
Group A
INDUCTION PHASE: 6 cycles of FOLFIRI + aflibercept MAINTENANCE PHASE: 5FU/LV + aflibercept
Intervention: 5-FU
Group B
FOLFIRI + aflibercept
Intervention: Aflibercept
Group B
FOLFIRI + aflibercept
Intervention: Irinotecan
Group B
FOLFIRI + aflibercept
Intervention: folinic acid (dl racemic)
Group B
FOLFIRI + aflibercept
Intervention: 5Fluorouracil
Group B
FOLFIRI + aflibercept
Intervention: 5-FU
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 48 months
Secondary Outcomes
- Disease control rate(48 months)
- Time to treatment failure(48 months)
- Time to progression(48 months)
- Overall survival(48 months)
- Objective response rate based on the RECIST criteria(48 months)
- Depth of response(48 months)
- Incidence and severity of AEs CTCAE v4.03 criteria(48 months)
- Incidence of dose adjustments and compliance(48 months)
- VES-13 score (Vulnerable Elders Survey) as the utility measure for health deterioration(48 months)
Study Sites (1)
Loading locations...
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