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Colon Cancer clinical trials

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NCT ID: NCT00923520 Completed - Breast Cancer Clinical Trials

A Phase 1, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612) in Advanced Malignancies

Start date: March 25, 2009
Phase: Phase 1
Study type: Interventional

Background: - Dimethane sulfonate (DMS612) is an investigational drug that is being administered to humans for the first time in people with advanced tumors. More information on the maximum tolerated dose of DMS612 will help researchers identify whether the drug is suitable for use in treating certain kinds of cancer, particularly renal cell carcinoma. Objectives: - To determine the maximum tolerated dose of DMS612 (the highest dose that does not cause unacceptable side effects) and evaluate any side effects. - To see if DMS612 has any effect on patients tumors through blood tests and laboratory studies. - To learn how the body processes DMS612. Eligibility: - Patients 18 years of age and older who have been diagnosed with cancer that has not responded well to standard treatments. Design: - Pre-treatment evaluation visit to determine eligibility: - Physical examination - Blood and urine tests - Chest X-ray; electrocardiogram; CAT scan of chest, abdomen, pelvis, and other areas of the body if needed - Other possible tests, such as magnetic resonance imaging (MRI) or positron emission tomography (PET) - Patients will receive one dose of DMS612 by intravenous infusion once a week for 3 weeks, followed by 1 week without the drug. Doses will be adjusted based on possible side effects and cancer response. The disease will be evaluated after three cycles of the drug. - Evaluations during the treatment period: - Physical examination and reviews of side effects. - Blood draws to evaluate the effectiveness of the drug, and how it is processed by the body. - CAT scan at the end of every two cycles (every 8 weeks). - Other scans and imaging procedures as required by the study doctors.

NCT ID: NCT00911170 Completed - Cancer Clinical Trials

PAVES: Pegfilgrastim Anti-vascular Endothelial Growth Factor (VEGF) Evaluation Study

Start date: November 3, 2009
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, placebo-controlled multi-center study evaluating the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia (FN) in patients with newly diagnosed, locally-advanced or metastatic colorectal cancer receiving first-line treatment with bevacizumab and either 5-fluorouracil, Oxaliplatin, Leucovorin (FOLFOX) or 5-fluorouracil, Irinotecan, Leucovorin (FOLFIRI). This study will also investigate the effect of adding pegfilgrastim to bevacizumab and either FOLFOX or FOLFIRI by evaluating overall survival, progression-free survival, and overall response rate in each arm at regular intervals over a maximum of 60 months follow-up.

NCT ID: NCT00909558 Suspended - Breast Cancer Clinical Trials

Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.

NCT ID: NCT00903565 Active, not recruiting - Colon Cancer Clinical Trials

A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint

PARSC
Start date: September 2008
Phase:
Study type: Observational

The aim of this study is to enroll 785 eligible stage II colon cancer patients in order to validate the performance of ColoPrint in estimating 3-year relapse rate. Secondary objectives include comparing the objective risk assessment results from the prognostic profile (ColoPrint) to both the risk assessment based on the ASCO criteria, as well as the Investigator's independent assessment. As this is the first prospective study of ColoPrint, this study will also address the logistics and quality assurance of using ColoPrint in clinical practice. Patient treatment is at the discretion of the physician, adhering to National Comprehensive Cancer Network (NCCN)-approved regimens or a recognized alternative. The enrollment period will be 6 years. It is expected that 1800 to 2400 patients will be enrolled in order to obtain 785 analysable stage II samples from eligible patients. Approximately 25-35 clinical sites will be involved worldwide. The statistical analysis will be performed by Agendia and an independent research institute or hospital. Study Design Extension Study: This will be a prospective study to measure the impact of ColoPrint on adjuvant treatment in stage 2 colorectal cancer patients. After surgery the tumor sample will be shipped in RNA Retain to Agendia. The online Clinical Report Form (CRF) 0 will be completed to document if the patient fulfils the inclusion criteria. Baseline clinical data and the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict without knowing the ColoPrint result will be entered in CRF 1. After completion of CRF1 the ColoPrint result is released. CRF2 will be completed after the final treatment decision has been made. This CRF will capture the patient and physician chemotherapy intention, patient's perceived recurrence risk and decisional conflict, impact of ColoPrint and the actual treatment the patient will receive. CRF3 will be completed 12 months after enrolment and will capture the patient status, patient's perceived recurrence risk and decisional conflict. CRF4 and 5 will be completed 3 and 5 years after surgery and will capture the patient status. A sample size of 210 stage 2 colon cancer patients is required to detect a 10% overall treatment change (5% significance and 90% power). Reporting of the Results: Blinded Study; The ColoPrint results will not be reported to the physician and/or patient at the time of enrolment. All samples will be stored in a freezer until 550-575 eligible stage II patients have been enrolled. Samples will then be analyzed in one batch in a blinded fashion from the clinical results. Extension Study; The ColoPrint results will be reported to the physician and patient after CRF1 has been completed.

NCT ID: NCT00896454 Completed - Breast Cancer Clinical Trials

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium

Start date: November 16, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9 millimoles /L) by day 10.

NCT ID: NCT00894725 Completed - Colon Cancer Clinical Trials

Laparoscopic Versus Open Left Colonic Resection

Start date: February 2000
Phase: Phase 3
Study type: Interventional

The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection. 268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

NCT ID: NCT00892593 Recruiting - Colon Cancer Clinical Trials

Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

ASC-FIT
Start date: May 2009
Phase: N/A
Study type: Interventional

The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.

NCT ID: NCT00890188 Recruiting - Colon Cancer Clinical Trials

Thalidomide and Tegafur/Uracil(UFUR) in the Treatment of Advanced Colorectal Cancer

UFUR
Start date: January 2009
Phase: Phase 2
Study type: Interventional

Colorectal cancer is a major health problem in Western society contributing to a high mortality rate. Treatment options for the majority of patients with metastases are limited to cytotoxic chemotherapies. The first line chemotherapy containing with oxaliplatin is recommend by guideline. The use of antiangiogenic agents, either alone or in combination with other therapies may provide an alternative treatment modality in the management of these patients. Metronomic chemotherapy refers to the close, regular administration of a chemotherapeutic drug, over prolonged periods. The advantages of metronomic chemotherapy include reducing acute toxicities and sometimes surprisingly good activity against drug resistant tumors via antiangiogenic effect. Thalidomide is an agent, which has shown potential in the treatment of hematological and solid tissue malignancies such as multiple myeloma via antiangiogenic mechanism. Tegafur/uracil (UFUR) is one of the effective chemotherapeutics reported to be an effective antiangiogenic agent in an animal model of metastatic colorectal cancers (CRCs). In the present study, the investigators will try to use low dose metronomic schedule of thalidomide with tegafur/uracil regimen to see the anti tumor efficacy in recurrent and metastasis colorectal cancer patients after oxaliplatin-contained chemotherapy. The primary endpoints are overall response rate and clinical benefit and the secondary endpoint were to determine the progression free survival, and duration of objective response, the overall survival (OS) and to assess the safety profile. This is a prospective phase II study. After having checked all eligibility criteria, patients will be treated with Tegafur/Uracil (TU) regimen. About 34 patients will be enrolled.

NCT ID: NCT00876954 Completed - Colon Cancer Clinical Trials

Preoperative Hyperthermia in Major Abdominal Surgery Patients

Start date: April 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

NCT ID: NCT00867724 Completed - Rectal Cancer Clinical Trials

Clinical Study-evaluate Performance&Safety "Aer-O-Scope" in Colon of Low Risk Patients

Start date: September 2009
Phase: N/A
Study type: Interventional

A double center study to evaluate the safety and efficacy of the Aer-O-Scope in traveling through the colon in low risk subjects.