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Cetuximab Plus Biweekly Capecitabine and Oxaliplatin in KRAS Wild Type Metastatic Colorectal Cancer
Phase 2 trial testing Cetuximab in Colorectal Cancer in 36 participants. Completed in 1 June 2015.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 1 June 2004 |
| Primary completion | 1 August 2012 |
| Estimated completion | 1 June 2015 |
| Sites | 2 locations across United States |
NYU Langone Health — full company profile →
18 and older, any sex, with Colorectal Cancer or Neoplasm Metastasis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The tumor response rate (RR) will be defined as the total number of subjects whose best response is partial response (PR) or complete response (CR) during the first six months of treatment, divided by the number of subjects.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab, Capecitabine and Oxaliplatin | 21 |
\# of subjects who experienced \>= grade 1 adverse event that is positively related to treatment.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab, Capecitabine and Oxaliplatin | 36 |
Time to Treatment Failure (progression or death) will be defined as the time from the first day of treatment until the date Progressive Disease (PD) or death is first reported. Subjects who die without a reported prior progression will be considered to have progressed on the day of their death. Subjects who did not progress will be censored at the day of their last tumor assessment.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab, Capecitabine and Oxaliplatin | 275 | 43 – 2822 |
Survival will be defined as the number of days from the first day of therapy to the date of death. If the subject is lost to follow-up, survival will be censored on the last date the subject was known to be alive.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab, Capecitabine and Oxaliplatin | 417 | 43 – 4166 |
Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cetuximab, Capecitabine an… |
|---|---|---|
| diarrhea | Gastrointestinal disorders | — |
| dehydration | Gastrointestinal disorders | — |
| Obstruction - Gi | Gastrointestinal disorders | — |
| fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Infection | Immune system disorders | — |
| Sepsis | Infections and infestations | — |
| Abdominal Pain | Gastrointestinal disorders | — |
| Shortness Of Breath | Respiratory, thoracic and mediastinal disorders | — |
| Vasovagal Episode | Cardiac disorders | — |
| hypotension | Cardiac disorders | — |
| seizure | Nervous system disorders | — |
| Thrombosis | Cardiac disorders | — |
| Death | Cardiac disorders | — |
| Hemorrage/ Bleeding | Blood and lymphatic system disorders | — |
| colitis | Gastrointestinal disorders | — |
| Cardiopulmonary Arrest | Cardiac disorders | — |
| Fistula | Gastrointestinal disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Weight loss | Metabolism and nutrition disorders | — |
| Disease progression on study | Gastrointestinal disorders | — |
| Reaction | System | Cetuximab, Capecitabine an… |
|---|---|---|
| Nausea | General disorders | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — |
| Neuropathy-sensory | Nervous system disorders | — |
| Diarrhea - patients without colostomy | Gastrointestinal disorders | — |
| Fatigue (lethargy, malaise, asthenia) | General disorders | — |
| Anorexia | Psychiatric disorders | — |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) | General disorders | — |
| Abdominal pain or cramping | Gastrointestinal disorders | — |
| Dermatology/Skin-Other | Skin and subcutaneous tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Gastrointestinal-Other | Gastrointestinal disorders | — |
| Dizziness/lightheadedness | Nervous system disorders | — |
| Dyspepsia/heartburn | Gastrointestinal disorders | — |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | — |
| Fever (in the absence of neutropenia) | General disorders | — |
| Flatulence | Gastrointestinal disorders | — |
| Dehydration | General disorders | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Alkaline phosphatase | General disorders | — |
| Diarrhea - patients with a colostomy | Gastrointestinal disorders | — |
| Edema | Blood and lymphatic system disorders | — |
| Bicarbonate | Renal and urinary disorders | — |
| Cardiovascular/Arrhythmia-Other | Cardiac disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Constitutional Symptoms-Other | General disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dysphagia, esophagitis, odynophagia (painful swallowing) | General disorders | — |
| Allergic reaction/hypersensitivity (including drug fever) | General disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Arthralgia (joint pain) | Musculoskeletal and connective tissue disorders | — |
| Ascites (non-malignant) | Gastrointestinal disorders | — |
| bilirubin | Hepatobiliary disorders | — |
| Blood/Bone Marrow-Other | Blood and lymphatic system disorders | — |
| Bruising (in absence of grade 3 or 4 thrombocytopenia) | Blood and lymphatic system disorders | — |
| Dry Eye | Eye disorders | — |
| Dysuria (painful urination) | Renal and urinary disorders | — |
| Erectile impotence | Reproductive system and breast disorders | — |
| Febrile neutropenia | Immune system disorders | — |
| Fistula-intestinal | Gastrointestinal disorders | — |
| Flushing | General disorders | — |
Most-reported serious reactions: diarrhea, dehydration, Obstruction - Gi, fatigue, Nausea, Vomiting, Infection, Sepsis.
Data from ClinicalTrials.gov NCT00444678 adverse events section.
This is a Phase II, open label, non-randomized study in subjects with histologically confirmed diagnosis of advanced KRAS wild type adenocarcinoma of the colon or rectum, who have not received prior chemotherapy for metastatic disease.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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