This trial is evaluating whether CP-675,206 (Tremelimumab) will improve 5 primary outcomes and 1 secondary outcome in patients with Colorectal Cancer. Measurement will happen over the course of Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years..
This trial requires 37 total participants across 2 different treatment groups
This trial involves 2 different treatments. CP-675,206 (Tremelimumab) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Approximately 9,600 new cases of [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) are diagnosed a year in the United States. The mortality rate is much higher for colorectal cancer in this population than for other causes of cancer death.
About 95% of colorectal cancers begin as colorectal polyps. Having multiple polyps, advanced age or family history are risk factors for developing colorectal cancer. People with colorectal cancer may be healthier, have more polyps or be screened regularly than others. This screening may help to identify and manage polyps. The risk of dying from colorectal cancer is greater if familial adenomatous polyposis (FAP), Von Hippel–Lindau syndrome, or Lynch syndrome is diagnosed before age 45. Smoking does not help to prevent colorectal cancer. Regular screening for colorectal cancer may be recommended.
The cure of colorectal cancer is possible. The cure depends on what is the tumoral site of resection (tumor size), how has and how has not the surgical margin been removed, which TNM stage has, and the age at which the patient has been diagnosed.
Patients with colorectal cancer may complain of persistent or recurrent dyspepsia or other gastrointestinal symptom as well as non-specific symptoms such as fatigue, weight loss or rectal bleeding. Some patients have unexplained constipation. A high suspicion of colorectal cancer and colonoscopy can make the difference between life and death.
Symptomatic colorectal cancer most commonly presents with dyspesia, anaemia, iron deficiency, iron deficiency anaemia and weight loss. The risk of lymph node involvement is increased and there are more tumours larger than 2 cm. Symptoms of advanced disease include diarrhoea, abdominal distension, constipation, weight loss and anemia.
Common treatment options involve surgery, chemotherapy, radiation, endoscopic treatment, palliative care, or a combination of these. The most common type of surgery is a curative procedure. For more advanced colorectal cancer, treatment with chemotherapy or targeted therapy may be preferable. A more aggressive approach, called radical surgery, may be appropriate in some cases.
This trial is designed to evaluate the long-term response in patients treated with CP 675,206 for treatment of advanced or metastatic clear-cell renal cell carcinoma (RCC). Patients randomized to CP 675,206 will have their disease assessed by an independent imaging committee to confirm or refute disease progression and RCC stage. If disease progression is confirmed based on imaging, patients will continue on the therapy in an experimental investigation of anti-tumor immune activity.
Patients with local or liver metastases from local colorectal carcinomas have a median survival of 12 months. Patients with extra-sarcomatous colorectal tumours usually develop liver metastases, and they have a median survival of only 10 to 14 months.
Patients' characteristics were similar in the GOC and the trial. Trial entry criteria were similar, indicating they could be used as criteria for consideration of clinical trials. Trials needed few participants to detect significant treatment effect in this disease.
Tremelimumab monotherapy as monotherapy or combination therapy with Cisplatin and oxaliplatin does not confer an indication of clinical benefit in patients with metastatic colorectal cancer.
The pattern of genetic markers in this study of families with [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) appears not to be different from that to be expected in colorectal cancer occurring in the general population. Although our study was not designed to search for a cause for colorectal cancer, its results do indicate the need for further research.
Cp-675,206 was active in combination with radiotherapy in mice and in combination with standard of care chemotherapy in human CRC patients. However, the drug was generally well tolerated, without clinically relevant hepatotoxicity except in patients with high baseline grade of hepatic enzymes and no improvement was observable. Cp-675,206 may be a new therapeutic option for patients with CRC to warrant further investigation.