Active clinical trials for "Gastrointestinal Neoplasms"

The aim of this study is to evaluate the outcomes of transvaginal natural orifice specimen extraction (NOSE) in patients who are planning multiport laparoscopic surgery for resection of solid organs including kidney, liver, stomach, adrenal gland and bladder.

The primary objective of this study is to determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of Minnelide™ and to establish the dose of Minnelide™ recommended for future phase 2 protocol

This phase I trial using the EffTox design will evaluate activity and safety of alisertib, an Aurora A kinase inhibitor, when given in combination with the selective VEGFR inhibitor pazopanib in patients with advanced, previously treated non-hematologic solid tumors.

Capecitabine is a chemotherapy drug used to treat many types of cancer including bowel and stomach cancer. Unfortunately a side effect of this drug is that it causes heart problems including heart attacks. An alternative drug, called teysuno is used extensively in other countries instead of capecitabine and appears to have less of a bad effect on the heart whilst still killing cancer cells. This study will investigate the effect of these two drugs on the heart and blood vessels and will be the first of its kind in humans.

Octreotide (OCT) is a somatostatin analogue (SSA) available in a long-acting formulation, conventionally administered every 28 days at the maximum dose of 30 mg. Together with lanreotide, it is considered the therapy of choice in the control of endocrine syndromes associated with neuroendocrine tumors (NET)s. A complete or partial clinical response to SSA therapy is generally achieved in at least 50% of the patients with neuroendocrine syndrome. Many studies reported a clinical response in 70-90% of functioning NETs. In about 36-50% of the patients with progressive advanced well differentiated NET (WDNET), a stabilization of disease occurs after treatment with subcutaneous OCT. By developing long-acting slow-release SSA formulation, long-acting OCT (LAR), lanreotide-SR, lanreotide-Autogel, the patient's compliance to SSA therapy was improved and escape from treatment, which was common with the subcutaneous formulation, was avoided. However, rate of objective response was not significantly improved as compared to short-acting SSA. On the other hand, it has to be remarked that long-acting SSA are being used in NET patients at doses correspondent to the low doses of short-acting formulation. The higher commercially available doses of LAR is 30 mg, which is assumed to be comparable to 300 µg of short-acting OCT in the therapy of acromegaly. Only one study was designed to investigate the use of high-dose LAR (160 mg every 28 days). In this study, objective and hormonal responses in patients with progressive metastatic ileal NET non-responder to standard doses, was significantly elevated. However, this compound has never been commercialized and, of consequence, this first preliminary observation has not been confirmed by further studies. No systematic studies were performed with the commercially available long-acting SSA used in high-dose treatments. In patients with progressive locally advanced or metastatic NET, increase of the dose or reduction of the interval between injections is a relatively common "empirical" clinical practice, but no studies have been performed to evaluate safety and efficacy of this treatment schedule.

The investigators hypothesize IXO chemotherapy will have an improvement in response rate and acceptable toxicity for uncurable metastatic gastric cancer compared to historical controls.

The goal of this clinical research study is to learn if panitumumab can help to control advanced cancer of the small bowel or ampulla of Vater. The safety of this drug will also be studied.

This phase I trial studies the side effects and best dose of cixutumumab when given together with everolimus and octreotide acetate in treating patients with advanced low- or intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better treatment for neuroendocrine cancer.

Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous study, while cisplatin is widely used in the combination chemotherapy of gastric cancer. Pemetrexed has shown synergy with cisplatin in preclinical models and in various human cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The patients, who will give their consent for participating in this study, will be screened for their eligibility and on meeting pre-defined study eligibility criteria, they will receive an intravenous therapy of the combination of pemetrexed and cisplatin for number of times that in the opinion of their treating physician is appropriate for them. A response rate of 30% is considered as the minimum activity level of interest for this patient population.

This study will determine which of the two following treatment regimens provides greater benefit to patients with peritoneal carcinomatosis (gastrointestinal cancer that has spread throughout the abdomen): Surgical removal of tumors plus heated chemotherapy during surgery, followed by one dose of chemotherapy 7 to 12 days after surgery, followed 3 weeks later by 4 months of chemotherapy; or Surgical removal of tumors followed by 4 months of chemotherapy, starting 1 month after surgery. Patients 18 years of age and older with peritoneal carcinomatosis may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests; chest X-ray and computed tomography (CT) scans; review of pathology slides; electrocardiogram (EKG), bone scan, and brain magnetic resonance imaging (MRI), as needed; and laparotomy. Laparatomy is a surgical procedure in which an incision is made in the abdomen to look at the amount and location of tumors in the abdominal cavity. Patients whose surgery reveals that the tumors cannot be removed are taken off study. Those eligible for the study have their tumors removed during this screening laparotomy as part of the study procedure, as follows: All participants undergo laparotomy and removal of as much tumor as possible, as described above. Patients are then randomly assigned to one of two treatment groups: Group 1 - During laparotomy, after tumor removal, patients receive continuous hyperthermic peritoneal perfusion (CHPP) with the anti-cancer drug cisplatin. For CHPP, the cisplatin solution is heated and delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter. At the close of surgery, a small catheter, called a Tenckhoff catheter, is left in the abdomen and brought out through the skin. Between days 7 and 12 after surgery, one dose of fluorouracil and paclitaxel chemotherapy is delivered through this catheter. The catheter is removed following complete recovery from surgery and the patient is discharged from the hospital. Four to 6 weeks after the surgery, patients have CT scans of the chest, pelvis, and abdomen, and then begin intravenous (IV, through a vein) chemotherapy with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin. The chemotherapy is given in 4-week courses as follows: oxaliplatin on day 1, infused over 2 hours through a vein in the arm or neck; leucovorin on days 1 and 2, infused over 2 hours, followed by 5-fluorouracil over 22 hours; leucovorin and 5-FU repeated two weeks later on days 15 and 16. This regimen is repeated two weeks later. Between each week of chemotherapy is a week break. A course of chemotherapy consists of 28 days (two weeks of chemotherapy and two 1-week breaks). Patients may receive up to four courses (total of 16 weeks) unless their disease progresses or they cannot tolerate further doses. Doses of the chemotherapy can be reduced if the side effects are too severe. Group 2 - Patients follow the same procedure as those in Group 1 for laparotomy, CT imaging, and IV chemotherapy with oxaliplatin, 5-fluorouracil, and leucovorin. They do not receive CHPP or chemotherapy into the abdomen. All patients undergo repeat imaging tests six weeks after surgery and at the conclusion of the intravenous (IV) chemotherapy. They return for a physical examination and CT scans every three months for the first year, every four months for the next two years, and then every six months for up to five years after treatment. They are also asked to complete quality of life questionnaires before and after surgery, at the completion of chemotherapy, and at every follow-up visit.