Phase 3
Completed N=781
Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen
Colorectal Cancer Metastatic
Source: ClinicalTrials.gov NCT01571284 ↗
Enrolled (actual)
781
Serious AEs
34.9%
Results posted
Feb 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 769; 609; 272; 159 Participants
◆ Published Evidence
Emerging
19citations · ~3 / year
Aflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer: Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP).
Summary
Primary Objective:
To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants
Secondary Objective:
To document the Health-Related Quality of Life of aflibercept in this participants population
Linked Publications
-
Aflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer: Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
769; 609; 272; 159; 47; 208 | — |
| PRIMARY Number of Participants With Abnormal Hematological Parameters |
535; 14; 293; 13; 532; 72 | — |
| PRIMARY Number of Participants With International Normalized Ratio (INR) |
106; 0; 2; 2 | — |
| PRIMARY Number of Participants With Abnormal Electrolytes Parameters |
181; 32; 75; 1; 213; 5 | — |
| PRIMARY Number of Participants With Abnormal Renal and Liver Function Parameters |
161; 2; 130; 9; 342; 12 | — |
| PRIMARY Creatinine Clearance of Aflibercept Plus FOLFIRI |
71.4 | — |
| PRIMARY Number of Participants With Other Abnormal Biochemistry Parameters |
90; 6; 403; 30; 241; 6 | — |
| PRIMARY Number of Participants With Abnormal Non-Gradable Biochemistry Parameters |
135; 217; 41; 83; 60; 250 | — |
| PRIMARY Number of Participants With Proteinuria Events |
286; 123; 54; 5 | — |
| PRIMARY Number of Participants With Proteinuria Grade >=2 |
182 | — |
| PRIMARY Number of Participants With Urinary Protein-Creatinine Ratio (UPCR) |
265; 51; 24; 27 | — |
| PRIMARY Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension |
72; 4; 3 | — |
| PRIMARY Number of Participants With Cycle Delay and/or Dose Modification |
119; 660; 163; 39; 308; 97 | — |
| SECONDARY Mean Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 Score): Global Health Status |
68.61; -3.34; -4.70; -3.63; -3.97; -5.85 | — |
| SECONDARY Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales |
81.79; -3.73; -3.95; -4.62; -4.36; -6.99 | — |
| SECONDARY Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales |
29.16; 7.35; 8.40; 9.54; 7.89; 11.30 | — |
| SECONDARY Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score |
0.77; -0.02; -0.03; -0.04; -0.05; -0.07 | — |
| SECONDARY Change From Baseline in HRQL EQ-5D-3L VAS Score |
72.81; -1.85; -2.15; -2.20; -2.74; -3.10 | — |
Eligibility Criteria
Inclusion criteria
- Histologically or cytologically proven adenocarcinoma of the colon or rectum.
- Metastatic disease.
- Eastern Cooperative Oncology Group performance status 0-1.
- One and only one prior chemotherapeutic regimen for metastatic disease. This prior chemotherapy was an oxaliplatin containing regimen. Participants must had progressed during or after the oxaliplatin based chemotherapy. Participants relapsed within 6 months of completion of oxaliplatin adjuvant chemotherapy were eligible.
- Signed written informed consent obtained prior to inclusion.
Exclusion criteria
- Prior therapy with irinotecan.
- Inadequate bone marrow, liver and renal function: neutrophils 1.5 x upper normal limit (ULN), transaminases >3 x ULN (unless liver metastasis are present), alkaline phosphatase >3 x ULN (unless liver metastasis are present), serum creatinine > 1.5 x ULN.
- Less than 4 weeks from prior radiotherapy, prior chemotherapy, prior major surgery (or until the surgical wound were fully healed).
- Treatment with any investigational drug within the prior 30 days.
- Treatment with concomitant anticonvulsivant agents that were CYP3A4 inducers (phenytoin, phenobarbital, carbamazepine), unless discontinued >7 days.
- History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
- Prior malignancy (other than colorectal) including prior malignancy from which the participants had been disease free for 1 on morning spot urinalysis or proteinuria > 500 mg/24-h.
- Uncontrolled hypertension within 3 months prior to study inclusion.
- Participants on anticoagulant therapy with unstable dose of warfarin and/or had an out-of-therapeutic range INR within the 4 weeks prior to study inclusion.
- Evidence of clinically significant bleeding predisposition or underlying coagulopathy, non-healing wound.
- Pregnant or breast-feeding women.
- Participants with reproductive potential who were not agree to use an accepted effective method of contraception.
The above information wass not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01571284) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.