Neoplasms

Digestive System Diseases

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma

Pancreatic Neoplasms

Stomach Neoplasms

Liver Neoplasms

Carcinoma, Ductal

Rectal Neoplasms

Colonic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Intestinal Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Stomach Diseases

Colorectal Neoplasms

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Head and Neck Neoplasms

Esophageal Diseases

Liver Diseases

Esophageal Cancer

Pancreatic Cancer

Bile Duct Cancer

Stomach Cancer

Small Intestine Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Ropidoxuridine

Iodine

Cadexomer iodine

Beginning 30 minutes to 2 hours before radiation therapy, patients receive ropidoxuridine PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity. Beginning on day 8, patients undergo IMRT 5 days a week for 3 weeks in the absence of disease progression or unacceptable toxicity.

Intensity-Modulated Radiation Therapy

Laboratory Biomarker Analysis

Pharmacological Study

Timothy J Kinsella

This phase I trial studies the side effects and best dose of ropidoxuridine in treating patients with gastrointestinal cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment undergoing radiation therapy. Ropidoxuridine may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy.

PRIMARY OBJECTIVES:

I. To conduct a phase I dose escalation trial, to determine the safety and the maximum tolerated dose (MTD), of oral (po) IPdR (ropidoxuridine) given daily for 28 consecutive days with concurrent intensity-modulated radiation therapy (IMRT) in patients with advanced gastrointestinal cancers treated with palliative radiation.

SECONDARY OBJECTIVES:

I. To observe and record anti-tumor activity. II. To establish the pharmacokinetics of daily po dosing of IPdR x 28 days. III. To assess, for patients treated at the MTD, for biochemical evidence of IPdR effect in normal tissue (circulating granulocytes) and tumor tissue (in patients with accessible tumor tissue) by measuring %iododeoxyuridine (IUdR)-deoxyribonucleic acid (DNA) cellular incorporation by flow cytometry and high-pressure liquid chromatography (HPLC) analyses.

IV. To assess the use of %IUdR-DNA cellular incorporation (measured by the investigational laboratory assays of flow cytometry and HPLC) as an exploratory biomarker of IPdR for the following effects: the %IUdR-DNA tumor cell incorporation from day 8 tumor biopsies in gastrointestinal (GI) cancer patients receiving MTD doses of IPdR as an exploratory biomarker of tumor radiosensitization using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

V. To assess the use of %IUdR-DNA cellular incorporation (measured by the investigational laboratory assays of flow cytometry and HPLC) as an exploratory biomarker of IPdR for the following effects: the %IUdR-DNA cellular incorporation in patients' circulating granulocytes taken weekly during the 28-day IPdR MTD dose, on day 29, and week 8 as an exploratory biomarker of IPdR systemic toxicities to bone marrow as measured by complete blood count (CBC)/differential values.

OUTLINE: This is a dose-escalation study of ropidoxuridine.

Beginning 30 minutes to 2 hours before radiation therapy, patients receive ropidoxuridine PO once daily (QD) on days 1-28 in the absence of disease progression or unacceptable toxicity. Beginning on day 8, patients undergo IMRT 5 days a week for 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy

Phase I and Pharmacology Study of Oral 5-Iodo-2-Pyrimidinone-2'- Deoxyribose (IPdR) as a Prodrug for IUdR-Mediated Tumor Radiosensitization in Gastrointestinal Cancers

Correlate %IUdR-DNA incorporation in human gastrointestinal (GI) tumor biopsies in the proposed phase I and pharmacokinetic (PK) clinical trial in GI cancer patients receiving palliative abdominal and/or pelvic radiation therapy (RT) by linear regression.

Correlate %IUdR-DNA incorporation in human GI tumor biopsies in the proposed phase I and PK clinical trial in GI cancer patients receiving palliative abdominal and/or pelvic RT by linear regression.

Tumor response is the dependent variable and can be binomial (i.e. response versus \[vs.\] no response) or multinomial (i.e. complete response, partial response, stable disease or progressive disease) and the %IUdR-DNA incorporation is the independent variable.

National Cancer Institute (NCI)

Symptoms and General Pathology

Recurrence

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bone Density Conservation Agents

Imidazole

Fluorouracil

Capecitabine

Zoledronic Acid

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Enzyme Inhibitors

Patients undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Patients receive fluorouracil IV over 24 hours on day 1 weekly for 4 weeks or capecitabine PO every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.

Patients receive zoledronic acid IV over no less than 15 minutes 1 week prior to radiation therapy. Patients undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine PO as in Arm A. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.

Undergo hypofractionated stereotactic radiotherapy

Stereotactic Body Radiation Therapy

Chi Lin, MD, PhD

This randomized phase II trial studies how well hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid work in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes. Hypofractionated stereotactic body radiation therapy is a specialized radiation therapy that sends higher doses of x-rays over a shorter period of time directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Drugs used in chemotherapy, such as fluorouracil and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Zoledronic acid is used in cancer patients to reduce cancer symptoms and may make tumor cells more sensitive to radiation. Giving hypofractionated stereotactic body radiation therapy and fluorouracil or capecitabine with or without zoledronic acid may work better in treating patients with pancreatic cancer.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of hypofractionated radiation therapy concurrently with zoledronic acid (Zometa) and fluorouracil (5Fu) or capecitabine.

SECONDARY OBJECTIVES:

I. To examine the toxicity of Zometa while it is used concurrently with hypofractionated radiation therapy.

II. To evaluate local failure-free survival and overall survival, surgical resection rate and tumor response rate.

TERTIARY OBJECTIVES:

I. To quantify the amplitude of the expression of genes that are involved in cholesterol biosynthesis (ACAT2, DHCR7, ELFN2, FASN, SC4MOL, and SQLE) in pancreatic tumor tissue prior to and following the Zometa and radiation therapy if the pancreatic cancer tissue is available.

II. To measure Zometa pharmacokinetics at steady-state. III. To evaluate tumor and organ motion with 4 dimension(D) computed tomography (CT) and respiratory gating system and to evaluate the effect of tumor/organ motion on the dosimetry, local control and survival.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo hypofractionated stereotactic body radiation therapy in 5 fractions on days 1-5. Patients receive fluorouracil intravenously (IV) over 24 hours on day 1 weekly for 4 weeks or capecitabine orally (PO) every 12 hours starting the evening before day 1 of radiation therapy for 4 weeks as per standard of care. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.

ARM B: Patients receive zoledronic acid IV over no less than 15 minutes 1 week prior to radiation therapy. Patients undergo hypofractionated stereotactic body radiation therapy and receive treatment with fluorouracil IV or capecitabine PO as in Arm A. Patients then undergo surgery 6-8 weeks after completion of radiation therapy.

After completion of study treatment, patients are followed up for 30 days, every 3 months for the first year, every 4 months for the second year, and then every 6 months thereafter.

Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer

A Randomized Phase II Study of the Efficacy and Safety of Hypofractionated Stereotactic Radiotherapy and 5FU or Capecitabine With and Without Zometa in Patients With Locally Advanced Pancreatic Adenocarcinoma

Change in expression of genes involved in cholesterol biosynthesis in patients who undergo resection will be assessed.

The concentration of plasma zoledronic acid will be measured.in patients who received zoledronic acid

Safety variables to be analyzed are adverse events. Adverse events will be tallied for overall frequency (number and percentage of subjects), worst reported severity, and relationship to study drugs. Serious adverse events will be summarized similarly.

Time to local failure will be analyzed using Kaplan-Meier method

Time to death will be analyzed using Kaplan-Meier method

The number and proportion of patients undergoing complete resection will be reported.

The pathologic response will be scored from 0-9 by a pathologist, 0 is no response and 9 is complete response.

The size of tumor will be measured on CT/MRI before and after SBRT

The max and average SUV will be measured on PET before and after SBRT

The amplitude of 3D tumor/organ motion will be measured using 4D CT scans

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy	NCT02381561	Advanced Bile D... Stage II Esopha... Stage II Pancre... Stage IIA Esoph... Stage IIA Pancr... Stage IIB Esoph... Stage IIB Pancr... Stage III Colon... Stage III Esoph... Stage III Gastr... Stage III Liver... Stage III Pancr... Stage III Recta... Stage III Small... Stage IIIA Colo... Stage IIIA Esop... Stage IIIA Gast... Stage IIIA Rect... Stage IIIA Smal... Stage IIIB Colo... Stage IIIB Esop... Stage IIIB Gast... Stage IIIB Rect... Stage IIIB Smal... Stage IIIC Colo... Stage IIIC Esop... Stage IIIC Gast... Stage IIIC Rect... Stage IV Colon ... Stage IV Esopha... Stage IV Gastri... Stage IV Liver ... Stage IV Pancre... Stage IV Rectal... Stage IV Small ... Stage IVA Colon... Stage IVA Liver... Stage IVA Recta... Stage IVB Colon... Stage IVB Liver... Stage IVB Recta...	Intensity-Modul... Laboratory Biom... Pharmacological... Ropidoxuridine	18 Years -	National Cancer Institute (NCI)
Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy	NCT02381561	Advanced Bile D... Stage II Esopha... Stage II Pancre... Stage IIA Esoph... Stage IIA Pancr... Stage IIB Esoph... Stage IIB Pancr... Stage III Colon... Stage III Esoph... Stage III Gastr... Stage III Liver... Stage III Pancr... Stage III Recta... Stage III Small... Stage IIIA Colo... Stage IIIA Esop... Stage IIIA Gast... Stage IIIA Rect... Stage IIIA Smal... Stage IIIB Colo... Stage IIIB Esop... Stage IIIB Gast... Stage IIIB Rect... Stage IIIB Smal... Stage IIIC Colo... Stage IIIC Esop... Stage IIIC Gast... Stage IIIC Rect... Stage IV Colon ... Stage IV Esopha... Stage IV Gastri... Stage IV Liver ... Stage IV Pancre... Stage IV Rectal... Stage IV Small ... Stage IVA Colon... Stage IVA Liver... Stage IVA Recta... Stage IVB Colon... Stage IVB Liver... Stage IVB Recta...	Intensity-Modul... Laboratory Biom... Pharmacological... Ropidoxuridine	18 Years -	National Cancer Institute (NCI)
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer	NCT03073785	Pancreatic Aden... Recurrent Pancr... Stage I Pancrea... Stage IA Pancre... Stage IB Pancre... Stage II Pancre... Stage IIA Pancr... Stage IIB Pancr... Stage III Pancr... Stage IV Pancre...	Capecitabine Fluorouracil Laboratory Biom... Pharmacological... Stereotactic Bo... Zoledronic Acid	19 Years -	University of Nebraska

Spots Global Cancer Trial Database for stage iib pancreatic cancer ajcc v6 and v7