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Colorectal Cancer clinical trials

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NCT ID: NCT00327093 Terminated - Colorectal Cancer Clinical Trials

Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies (Cetuximab and Bevacizumab) in Patients With Colorectal Cancer and Liver Metastases

Start date: May 2006
Phase: Phase 4
Study type: Interventional

Primary Objective: This trial is elaborating a model for rapidly predicting (day 21) the response to monoclonal antibodies anti-EGFR and anti-VEGF (cetuximab and bevacizumab) based on biological markers and/or functional imaging. The response to treatment is evaluated by the conventional method after 2 months (Response Evaluation Criteria in Solid Tumors [RECIST] criteria). Secondary Objectives: 1. This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months (stabilization or objective response, RECIST criteria) and that of response observed after 6 months of treatment. 2. The organisational objective is to develop a tumour bank of metastatic colorectal cancer. Population: The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab, with no heart disease. Techniques: Computed tomography (CT scan), functional imaging (ultrasound with SonoVue); molecular imaging (positron emission tomography [PET] with fluorodeoxyglucose F18 [18-FDG]); and biology and pathology on microbiopsy of liver metastasis are used. Outcome Criteria: The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months. Studied Factors: Radiology: 1. CT scan: RECIST criteria (gold standard); 2. Ultrasound with SonoVue injection: 1 representative target (delay of contrast appearance, peak of rising, curve of increase and decrease of the signal, area under the curve, time of average transit). Nuclear Medicine: PET scan and 18-FDG (standard uptake values [SUV]) Molecular Characterization of Tumors: p53 status; microsatellite instability (MSI) status; expression of oncogenes; EGFR status; VEGF status; determination of FcgammaRIIIA polymorphisms Statistics: 1. Descriptive analyses; 2. Analysis of the appropriate threshold to measure: response to treatment by an ultrasound with SonoVue and by PET scan; correlation between response predicted by the ultrasound with SonoVue and the PET; conventional morphological CT at 2 months 3. Analysis of prognostic factors: 1. Evaluation of the role of each prognostic factor (pathology and imaging) on response to treatment; 2. Multivariate analysis of prognostic factors; 3. Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment.

NCT ID: NCT00323011 Terminated - Colorectal Cancer Clinical Trials

FOLFIRI + Bevacizumab With or Without Dalteparin in First Line Treatment of Advanced Colorectal Cancer

Start date: May 2006
Phase: Phase 2
Study type: Interventional

This study is for people with colorectal cancer, who have tumors that cannot be completely removed by surgery. Blood clots are a problem in patients with cancer. Blood clots are also a problem in patients receiving cancer drugs. Studies have shown that up to 17% of patients receiving cancer drugs experienced blood-clotting problems. One purpose of this study is to find if the drug combination of irinotecan, 5-fluorouracil (5-FU), bevacizumab and leucovorin (LV) affect blood-clotting factors. A second purpose of this study is to find out what effects the drug dalteparin has on clotting factors in the blood in patients receiving the drug combination of irinotecan, 5-FU, bevacizumab and LV. It is hoped that adding dalteparin to chemotherapy may benefit patients with colorectal cancer by preventing blood clots

NCT ID: NCT00305643 Terminated - Breast Cancer Clinical Trials

Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer

Start date: February 2006
Phase: Phase 3
Study type: Interventional

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen hand-foot syndrome caused by capecitabine. PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal cancer.

NCT ID: NCT00296062 Terminated - Colorectal Cancer Clinical Trials

Dose Dense Therapy and Bevacizumab in Solid Tumors and Colorectal Cancer

Start date: March 2006
Phase: Phase 1
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as capecitabine, irinotecan, 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 more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Bevacizumab may also block blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of capecitabine when given together with irinotecan and oxaliplatin with or without bevacizumab and to see how well they work in treating patients with metastatic or locally advanced colorectal cancer or other solid tumors that cannot be removed by surgery.

NCT ID: NCT00277303 Terminated - Colorectal Cancer Clinical Trials

Study of XL999 in Patients With Metastatic Colorectal Cancer

Start date: December 2005
Phase: Phase 2
Study type: Interventional

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with metastatic colorectal cancer (CRC). XL999 is a small molecule inhibitor of multiple kinases including VEGFR, PDGFR, FGFR, FLT-3, and Src, which are involved in tumor cell growth, formation of new blood vessels (angiogenesis), and metastasis.

NCT ID: NCT00276861 Terminated - Colorectal Cancer Clinical Trials

Gemcitabine and Oxaliplatin as Second-Line Therapy in Treating Patients With Metastatic Colon Cancer

Start date: September 2005
Phase: Phase 2
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as gemcitabine 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 more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.

NCT ID: NCT00271011 Terminated - Colorectal Cancer Clinical Trials

A Study of Mitomycin C, Irinotecan, and Cetuximab

Start date: December 2005
Phase: Phase 2
Study type: Interventional

Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned. This study will also evaluate any rash that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C, Irinotecan, and Cetuximab.

NCT ID: NCT00268463 Terminated - Colorectal Cancer Clinical Trials

Oxaliplatin and Capecitabine With or Without an Hepatic Arterial Infusion With Floxuridine in Treating Patients Who Are Undergoing Surgery and/or Ablation for Liver Metastases Due to Colorectal Cancer

Start date: January 2006
Phase: Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, capecitabine, and floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hepatic arterial infusion uses a catheter to carry tumor-killing substances, such as chemotherapy, directly into the liver. Giving chemotherapy in different ways may kill more tumor cells. It is not yet known whether giving oxaliplatin and capecitabine together with an hepatic arterial infusion with floxuridine is more effective than giving oxaliplatin and capecitabine alone in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer. PURPOSE: This randomized phase III trial is studying oxaliplatin, capecitabine, and an hepatic arterial infusion with floxuridine to see how well they work compared to oxaliplatin and capecitabine in treating patients who are undergoing surgery and/or ablation for liver metastases due to colorectal cancer.

NCT ID: NCT00264979 Terminated - Colorectal Cancer Clinical Trials

Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

METASYNC
Start date: March 2, 2006
Phase: N/A
Study type: Interventional

The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

NCT ID: NCT00251186 Terminated - Colorectal Cancer Clinical Trials

First-Line Capecitabine and Cetuximab for Metastatic Colorectal Ca in Elderly Patients

Start date: April 2006
Phase: Phase 2
Study type: Interventional

This is a Phase II clinical trial measuring the effectiveness of the combination of Capecitabine and cetuximab for first line treatment of colorectal cancer in elderly patients and/or those with multiple comorbidities unable to receive standard chemotherapy. This study will be open approximately 2-3 years. Approximately 36 patients will be enrolled on this study. The study will begin enrolling at The Cancer Institute of New Jersey, with 17 patients in the first group. If more than 4 responses are noted, the accrual will continue to 36 patients throughout CINJOG.