View clinical trials related to Colorectal Carcinoma.
Filter by:This study will assess the safety of panitumumab, irinotecan and everolimus when given in combination to treat advanced colorectal cancer
The purpose of this clinical trial is to primarily assess the efficacy of an intensified chemotherapy consisting of a combination of FOLFOXIRI + bevacizumab. The main focus will be laid on the rate of patients who achieve secondary complete (R0)-resectable metastases. The FOLFIRI + bevacizumab as well as the FOLFOXIRI regimens have been shown previously to be both effective in the treatment of advanced CRC with having manageable toxicities. Therefore, an intensified chemotherapy combining these two standard regimens might be a promising therapeutic approach improving the treatment of metastatic disease and outcome of CRC. Patients with advanced colorectal carcinoma of UICC stage IV, and liver and/or lung metasta¬ses only, which are not optimally resectable, will be enrolled in this single-arm phase II study. A minimum of 4 cycles (=8 weeks) of chemo¬therapy prior to surgery is mandatory for all patients. However, patients may withdraw from the study at any time upon their own request. Treatment with preoperative chemothera¬py will continue until 2-4 weeks prior to surgery with the last application of bevacizumab (only FOLFOXIRI) 4 weeks before surgery, at longest 16 cycles (= 32 weeks) for candidates not eli¬gible for surgery. Treatment will be discontinued prematurely at disease progression or unacceptable toxicity. As secondary endpoints the acute and perioperative toxi¬city of preoperative chemotherapy according to NCI CTCAE v 3.0 including all peri-and post-surgical complications as well as progression free survival and overall survival and quality of life will be assessed.
Background: - Survival rates for colorectal cancer depend on a number of factors, including the existence of tumors outside the colon and rectum. Patients who had tumors elsewhere in the abdomen (such as in the peritoneum or ovaries) when they were diagnosed, as well as patients who had bleeding or obstruction when they were diagnosed, have a high risk of cancer recurrence even after surgery or other treatment. - If additional tumors are discovered early and removed while they are still small (often before they can show up on scans), survival rates may improve. In addition, patients who receive a heated chemotherapy solution delivered directly to the abdomen often have better treatment outcomes regardless of whether additional tumors were found. Further research can help determine the usefulness of both of these treatments in improving the outcomes of patients with colorectal cancer. Objectives: - To determine whether patients who have had surgery for colorectal cancer have improved outcomes after receiving additional surgery combined with direct chemotherapy, compared with those who receive the current standard of care. Eligibility: - Individuals at least 18 years of age who have had surgery for colorectal cancer within the past 14 months, who are considered to be at high risk for cancer recurrence, and whose current imaging scans show no signs of additional tumors. Design: - Participants will be divided into two treatment groups: a surgery group and a standard of care group. - Participants who had surgery less than 11 months ago will be enrolled in a 3-month lead-in phase to receive standard follow-up care, including labs, scans, and physical examinations, before being randomized to a treatment group between 11 and 14 months after surgery. Participants who had surgery between 11 and 14 months ago will be randomized at the time of enrollment. - Participants in the surgery group will have the following procedures within 2 weeks of randomization: - Abdominal surgery where surgeons will look for and remove any tumors and take biopsies to check for cancer cells - Heated chemotherapy, with three chemotherapy drugs administered directly to the abdomen - In-patient recovery and follow-up visits beginning 3 to 6 weeks after discharge. - Participants in the standard of care group will have the standard follow-up schedule for high-risk colorectal cancer patients: - Clinic evaluations every 3 months for 2 years, and then every 6 months for 3 years and yearly thereafter....
The purpose of this study is to test how long participants with colorectal cancer live without progressive disease when being treated with IMC-1121B (ramucirumab) and the modified FOLFOX-6 chemotherapy.
This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at risk of colorectal cancer.
This study is being conducted in order determine whether IMA910 as single agent with GM-CSF as adjuvant following pre-treatment with low-dose cyclophosphamide is safe and shows sufficient anti-tumour effectiveness in patients with advanced CRC to warrant further development. Secondary objectives of this study are investigation of immunological parameters and additional effectiveness endpoints. Furthermore, safety, immunological parameters and effectiveness of IMA910 as single agent with GM-CSF in combination with imiquimod following pre-treatment with low-dose cyclophosphamide will be investigated in a 2nd cohort of patients. The regular study duration for individual patients in the 1st and 2nd cohort comprises regularly 18-42 days of screening (excluding HLA-typing), 33 weeks of treatment (16 vaccinations) and 4 weeks follow-up. Thus, the period between start of screening and end of trial is about 10 months per patient. Patients will be followed for response to subsequent treatments (chemotherapies with or without targeted agents) and survival every 2 months after EOS visit until death. Patients in the 1st and 2nd cohort will be withdrawn from study treatment once a progress according to RECIST is noted. An enrolment plan for the first 6 patients included into the 1st cohort will be part of this study to ensure maximum safety of the study participants. The enrollment of the first 6 patients into the 2nd cohort will also follow an enrolment plan to ensure maximum safety.
This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.
RATIONALE: Monoclonal antibodies, such as Cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.This is an anti-cancer drug which has already been approved by the FDA for use in patients who have Colorectal Cancer. Cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation Therapy uses high-energy x-rays to kill tumor cells and cause less damage to normal tissue . Giving the drug Cetuximab together with Radiation Therapy may kill more tumor cells. Surgery is the most common treatment for Colorectal Cancer to remove the tumor, as well as a small margin of surrounding normal tissue and possibly nearby lymph nodes. Surgery is usually used in conjunction with other conventional treatments such as Radiation Therapy. Radiation Therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation Therapy after surgery may kill any tumor cells that remain after surgery. Screening test such as Fecal Occult Blood Test (FOBT) and Colonoscopy has to be done. Tumor markers for Colorectal Carcinoma are Carcinoembryonic antigen (CAE) and CA 19-9 and to assess the response of tumor markers Carcinoembryonic antigen (CAE) and CA 19-9 will be used and periodically Colonoscopy has to be done. Colorectal Cancer Surgery are Colon resection (Colectomy), Rectum resection (Proctectomy), Colostomy, and Radiofrequency ablation. PURPOSE: Determine the tumor response rate treated with Cetuximab and Radiation Therapy Vs Surgery before or after Radiation Therapy in patients with Colorectal Cancer from stage II to IV
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma. Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.
The aim is to study safety and activity of nelfinavir , added to standard chemoradiotherapy in patients with locally advanced rectal cancer. Furthermore analysis of the effect of nelfinavir combined with chemoradiation on tumour tissue will be studied