Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy

Description

This phase I trial studies the side effects and best dose of ropidoxuridine in treating patients with gastrointestinal cancer that have 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.

Study Start Date

February 2016

Estimated Completion Date

July 2017

Interventions

  • Other: Laboratory Biomarker Analysis
  • Drug: Ropidoxuridine
  • Radiation: Intensity-Modulated Radiation Therapy
  • Other: Pharmacological Study

Specialties

  • Gastroenterology: Biliary System/Pancreas,GI Oncology
  • Oncology: GI Oncology
  • Radiology: Radiotherapy (XRT)
  • Physician Assistant: Gastroenterology,Hematology/Oncology

MeSH Terms

  • Pancreatic Neoplasms
  • Ropidoxuridine

Study ID

National Cancer Institute (NCI) -- NCI-2015-00258

Status

Unknown

Trial ID

NCT02381561

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

30

Sponsor

National Cancer Institute (NCI)

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed advanced, incurable cancers of the stomach, small bowel, pancreas, bile duct, colon or rectum and eligible to receive abdominal and/or pelvic radiation therapy (RT) for palliation
  • documentation of this is required in physician note
  • Patients must not have received systemic chemotherapy for at least 4 weeks, and must not have received prior radiation therapy to the tumor site being irradiated on this study
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 12 weeks
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 × institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control
  • abstinence) prior to study entry and for the duration of study participation should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of IPdR administration
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients who are receiving any other investigational agents
  • Patients with known brain metastases should be excluded from this clinical trial
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to IPdR
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study
  • breastfeeding should be discontinued if the mother is treated with IPdR
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Rhode Island Hospital - Providence, Rhode Island 41.0 miles Timothy J Kinsella 401-444-8311 tkinsella@lifespan.org

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