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Aflibercept and FOLFOX6 Treatment for Previously Untreated Stage IV Colorectal Cancer
Phase 2 trial testing aflibercept in Mucinous Adenocarcinoma of the Colon in 56 participants. Completed in 30 August 2022.
| Lead sponsor | John Hays |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 14 November 2012 |
| Primary completion | 6 August 2019 |
| Estimated completion | 30 August 2022 |
| Sites | 6 locations across United States |
John Hays
18 and older, any sex, with Mucinous Adenocarcinoma of the Colon or Mucinous Adenocarcinoma of the Rectum. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assuming that the number of treatment successes (alive and progression-free) is binomially distributed, proportion estimates along with their corresponding exact 95% confidence intervals will be calculated.
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | .482 |
Summarized as a proportion with corresponding 95% confidence interval.
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 0.446 |
Summarized as a proportion with corresponding 95% confidence interval.
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 5.36 |
Will be evaluated using the methods of Kaplan and Meier.
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 7.82 | 7.36 – 10.71 |
Will be evaluated using the methods of Kaplan and Meier.
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 19.68 | 16.23 – 25.79 |
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 33.9 |
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 25 |
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 12.5 |
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 10.7 |
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 50 |
| Group | Value | 95% CI |
|---|---|---|
| Aflibercept (Combination Chemotherapy) | 2 |
Time frame: Adverse Events were collected and graded for patients from start of study until study completion up to an average of 4 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Aflibercept (Combination C… |
|---|---|---|
| Thromboembolic event | Vascular disorders | — |
| Hypertension | Vascular disorders | — |
| Non-Cardiac Chest Pain | General disorders | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Fever | General disorders | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Nausea | Gastrointestinal disorders | — |
| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | — |
| Pericardial effusion | Cardiac disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Vascular access complication | Injury, poisoning and procedural complications | — |
| Vomiting | Gastrointestinal disorders | — |
| Wound complication | Injury, poisoning and procedural complications | — |
| Colonic perforation | Gastrointestinal disorders | — |
| Colonic obstruction | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Catheter related infection | Infections and infestations | — |
| Ileal obststruction | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Syncope | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Creatinine increased | Investigations | — |
| Reaction | System | Aflibercept (Combination C… |
|---|---|---|
| Nausea | Gastrointestinal disorders | — |
| Hypertension | Vascular disorders | — |
| Fatigue | General disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Platelet count decreased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypertriglyceridemia | Metabolism and nutrition disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Cholesterol high | Investigations | — |
| Proteinuria | Renal and urinary disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Dyspnea | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Weight loss | Investigations | — |
| Alanine aminotransferase increased | Investigations | — |
| Paresthesia | Nervous system disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Dysgeusia | Nervous system disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | — |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | — |
| Thromboembolic event | Vascular disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Creatinine increased | Renal and urinary disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Thromboembolic event, Hypertension, Non-Cardiac Chest Pain, Abdominal Pain, Dyspnea, Fever, Infusion related reaction, Nausea.
Data from ClinicalTrials.gov NCT01652196 adverse events section.
This phase II trial studies how well giving aflibercept together with combination chemotherapy works in treating patients with previously untreated colon or rectal cancer that is metastatic or locally advanced and cannot be removed by surgery. Aflibercept may stop the growth of colon or rectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving aflibercept together with combination chemotherapy may kill more tumor cells
3 peer-reviewed publications reference this trial (live from Europe PMC):
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