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Adenocarcinoma clinical trials

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NCT ID: NCT02628379 Completed - Metastatic Disease Clinical Trials

Outcomes of FoundationOne Directed Therapy in Cancer of Unknown Primary

Start date: May 2015
Phase:
Study type: Observational

The goal of the current study is to determine whether Foundation Medicine's next generation sequencing assay, called FoundationOne, will provide information that allows physicians to make treatment decisions using targeted therapies in clinical trials or FDA approved therapies, including "off-label" agents, that result in superior OS compared to historical outcomes for standard CUP therapy.

NCT ID: NCT02625623 Completed - Clinical trials for Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

Start date: December 28, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority of treatment with avelumab plus best supportive care (BSC) versus physician's choice (chosen from a pre-specified list of therapeutic options) plus BSC.

NCT ID: NCT02625610 Completed - Clinical trials for Unresectable, Locally Advanced or Metastatic, Adenocarcinoma of the Stomach, or of the Gastro Esophageal Junction

Avelumab in First-Line Maintenance Gastric Cancer (JAVELIN Gastric 100)

Start date: December 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority of treatment with avelumab versus continuation of first-line chemotherapy.

NCT ID: NCT02624518 Completed - Clinical trials for Prostate Adenocarcinoma

68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer

Start date: November 16, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Prostate cancer (PC) remains the most-common non-cutaneous cancer diagnosed in American males, accounting for an estimated 174,560 estimated new cases and 31,620 estimated deaths in 2019. Up to 40% of the patients with prostate cancer develop biochemical recurrence within 10 years after initial treatment. Usually an increase of the prostate-specific antigen (PSA) llevel precedes a clinically detectable recurrence by months to years, and this is currently used as a screening test before and subsequent to treatment. However, disease advancement can be local, regional or systemic, and each has significantly different approaches to disease management. Unfortunately, PSA level does not differentiate between these disease stages. This phase 2-3 study explores the utility of radiolabel 68Ga-RM2, a 68-gallium (68Ga)-labeled gastrin-releasing peptide receptor (GRPr) antagonist, for positron emission tomography (PET) / magnetic resonance imaging (MRI) (collectively, PET/MRI) as a potential tool to help discriminate between disease stages in participants after treatment with surgery or radiation, who present persistently elevated PSA levels (ie, may have prostate cancer), but were negative for cancer with a diagnostic regular medical care computed tomography (CT) scan 68Ga-RM2 (BAY86-7548) is also identified as a synthetic bombesin receptor antagonist. PET/MRI is the collective result of 2 scan processes (PET and MRI ) conducted during the same scan procedure (ie, a combined scan). After a regular medical care computed tomography (CT) scan, participants will be scanned with 68Ga-RM2 PET/MRI scan procedure. PET/MRI is used to assess the location, size, and metabolic activity of a suspected tumor. The 68Ga-RM2 radiolabel consisted of a ligand (the synthetic bombesin receptor antagonist) and the radioisotope 68Ga. The RM2 ligand targets gastrin-releasing peptide receptors (GRPr), commonly expressed by prostate cancer cells, and the radioisotope distinguishes those cells from the background. The criteria for scan "positivity" will be, when compared to background level of the liver (control), the 68Ga signal is stronger (positive - malignant) or weaker (negative - benign). This study will assess how well 68Ga-RM2 works in detecting prostate cancer in patients with 68Ga-RM2 PET/MRI may be able to see smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

NCT ID: NCT02624115 Completed - Clinical trials for Colon Rectal Cancer Adenocarcinoma

FAZA PET as Biomarker for Hypoxia in Rectal Cancer

Start date: May 1, 2016
Phase:
Study type: Observational [Patient Registry]

Colorectal cancer (CRC) is one of the leading causes of cancer mortality in Canada. Rectal cancers are now known to be hypoxic which is a negative prognostic factor and predictive of metastatic spread and poor responsiveness to treatment. This has also been shown in preclinical xenograft models. Hence there is a need for identification of hypoxic rectal cancers. In this pilot study the investigators intend to non-invasively assess the tumor and nodal metastasis using an integrated Positron Emission Tomography-Magnetic Resonance Imaging scanner (PET/MRI) with 18F-Fluoroazomycin Arabinoside (18F-FAZA) a radiopharmaceutical for assessing tumor hypoxia. The hypoxic rectal tumors will show an increased uptake of 18F-FAZA on PET which will have morphological correlation on MRI. The patient will then undergo neoadjuvant chemoradiation therapy (CRT) followed by repeat 18F-FAZA PET/MRI and rectal cancer surgery with pimonidazole staining. Pimonidazole is an extrinsic marker of hypoxia that is selectively reduced and covalently bound to intracellular macromolecules in areas of hypoxia within normal and tumor tissue with current approval for use in humans for research studies. The primary goal of this pilot trial is to validate FAZA-PET as a biomarker of hypoxia by correlating its uptake in rectal tumors to pimonidazole staining in histopathology specimens. If the investigators pilot study successfully demonstrates the uptake and correlation of pimonidazole and FAZA-PET, the investigators would like to initiate a larger study examining hypoxia in rectal cancer. The investigators aims would be to image patients with locally advanced rectal cancer before CRT to ascertain whether high FAZA-PET uptake correlates with poor outcome to CRT. The ability to preoperatively predict the patient sub-population that will respond best to CRT, will help to identify the "complete pathological" responders and avoid unnecessary surgery. Furthermore, the FAZA-PET high subset of patients may benefit from other treatment strategies including clinical trials of anti-hypoxic agents.

NCT ID: NCT02620800 Completed - Clinical trials for Metastatic Pancreas Adenocarcinoma

Study of 5-fluorouracil (5-FU), Nab®1-paclitaxel, Bevacizumab, Leucovorin, and Oxaliplatin in Patients With Metastatic Pancreatic Cancer

FABLOx
Start date: January 18, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about the safety and potential benefit of metronomic 5-fluorouracil in combination with nab®1-paclitaxel, bevacizumab, leucovorin, and oxaliplatin in treating patients with metastatic pancreatic adenocarcinoma.

NCT ID: NCT02620423 Completed - Clinical trials for Pancreatic Adenocarcinoma

Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma

Start date: December 2015
Phase: Phase 1
Study type: Interventional

The purpose of this Phase 1b study is to investigate whether intravenous administration of REOLYSIN® in combination with chemotherapy and pembrolizumab is effective and safe in the treatment of pancreatic adenocarcinoma.

NCT ID: NCT02615730 Completed - Clinical trials for Advanced Gastric Adenocarcinoma

PI3Kβ Selective Inhibitor With Paclitaxel, Advanced Gastric Adenocarcinoma

Start date: February 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-deficient, advanced gastric adenocarcinoma. This study will be conducted in two phases: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase (Phase Ib) is designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of GSK2636771 administered in combination with paclitaxel. The Dose Expansion Phase (Phase IIa) will further evaluate the safety and clinical activity of the RP2D as determined in the Dose Escalation Phase.

NCT ID: NCT02610764 Completed - Clinical trials for Esophageal Adenocarcinoma

Pilot Sudy: Resectable Esophageal Adenocarcinoma and the Relevance of CTC

ESO-CTC
Start date: November 2015
Phase: N/A
Study type: Interventional

To investigate the feasibility of evaluation of prevalence and clinical significance and relevance of circulating tumor cells (CTC) in the blood of patients with resectable adenocarcinoma of the esophagus (EAC) treated with multimodal therapy in a pilot study. The primary hypothesis is that the number of CTC correlates with tumor burden and response to treatment. One established and one experimental CTC detection platform will be investigated. Investigators will evaluate the prevalence and enumeration of CTC before neoadjuvant treatment (time point 1), after neoadjuvant treatment & before operation (time point 2) and after the operation (time point 3). Results will be compared with healthy controls (one time point) and correlated with conventional response to treatment evaluation. The persistent presence of CTC could be a marker for worse response to treatment and predict early recurrence.

NCT ID: NCT02603965 Completed - Clinical trials for Prostate Adenocarcinoma

Copper Cu 64 TP3805 PET in Detecting Cancer in Patients With Prostate Cancer Undergoing Surgery

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This pilot phase I trial studies copper Cu 64 TP3805 (Cu-64-TP3805) positron emission tomography (PET)/computed tomography (CT) in detecting cancer in patients with prostate cancer undergoing surgery to remove the entire prostate and some of the tissue around it (radical prostatectomy). Many patients with benign lesions must undergo biopsy to test the lesion. Cu-64-TP3805 is a radioactive substance that attaches to cancer cells but not normal cells. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body where the radioactive substance is lighting up. Using Cu-64-TP3805 PET/CT scans and comparing them with cancer tissue obtained from surgery may help doctors learn whether Cu-64-TP3805 PET/CT can accurately detect prostate lesions and determine whether they are cancerous or benign, which may minimize the need for prostate biopsies.