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A221805 - Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A221805 - Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study
 
Region Sponsors
Mid-Atlantic
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
 
Acronym KP IRB No.
1895168
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Patients with stage II-III colorectal cancer who are scheduled to take oxaliplatin.
 
Purpose
This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Stage II-III colorectal cancer patients scheduled to receive oxaliplatin 510 mg/m^2 (cumulative dose) over 12 weeks as a component of adjuvant leucovorin calcium (calcium folinate), 5-fluorouracil and oxaliplatin (FOLFOX) treatment, in which patients are scheduled to receive oxaliplatin 85 mg/m^2 every 2 weeks for 12 weeks (i.e., 6 cycles), or adjuvant capecitabine and oxaliplatin (CAPOX) treatment, in which patients are scheduled to receive oxaliplatin 135 mg/m^2 every 3 weeks for 12 weeks (i.e., 4 cycles)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • In order to complete the mandatory patient-completed measure, patients must be able to speak and read English
  • Calculated creatinine clearance > 30 mL/min
  • Aspartate aminotransferases (AST)/serum glutamic-oxaloacetic transaminase (SGOT) =< 3 x upper limit of normal (ULN)
 
Exclusion Criteria
  • No prior neurotoxic chemotherapy
  • No pre-existing clinical or pre-clinical peripheral neuropathy from any cause.
  • No history of seizure disorder,
  • No history of narrow-angle glaucoma.
  • No symptoms of or history of schizophrenia, bipolar disease, suicidal thoughts and/or a major depression.
  • No serious eating disorder such as bulimia or anorexia.
  • No known diagnosis of ethanol (ETOH) addiction/dependence within the past 10 years.
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential, a negative pregnancy test done =< 7 days prior to registration is required

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Burke Medical Center
  • Capitol Hill Medical Center
  • Gaithersburg Medical Center
  • Largo Medical Center
  • Tyson's Corner Medical Center
  • Woodlawn Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Leon Hwang, MD
Contact Information:


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