Status:
COMPLETED
Evaluate The Efficacy and Safety Of Pregabalin In Prevention, Reduction of Oxaliplatin-Induced Painful Neuropathy
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Pfizer
Conditions:
Pain
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Oxaliplatin (Ox) is part of most treatment regimens for colorectal cancer. However, it may induce side effects, such as a specific injury to peripheral nerves called neuropathy. Ox-induced neuropathy ...
Detailed Description
1\. OBJECTIVES 1.1. Primary Objectives The primary objective of this study is to evaluate the efficacy of co-administration of Pregabalin during oxaliplatin infusion in reducing the appearance of bo...
Eligibility Criteria
Inclusion
- Patient must have histologically or cytologically confirmed colorectal cancer
- Indication of adjuvant chemotherapy regime including oxaliplatin
- Age ≥ 18 years
- Karnofsky performance status (KPS) ≥ 50
- Normal neurological examination
- Be able to understand study protocol
- Ability to understand and the willingness to sign a written informed consent document.
- The effects of Pregabalin on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing 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 participating in this study, she should inform her treating physician immediately.
Exclusion
- History of exposure to neurotoxic chemotherapy
- Know Concomitant clinical conditions that impair peripheral nerve function,
- Symptoms or signs suggestive of peripheral neuropathy or neuropathic pain.
- Current peripheral neuropathy of NCI-CTCAE, version 3.0 Grade ≥ 1.
- Inadequate organ function, evidenced by the following laboratory results within 1 week prior to randomization:
- Serum creatinine \> 2.0 mg/dL
- Positive blood beta HCG test for women, or women breast feeding
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- History of receiving any investigational treatment within 28 days of randomization
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pregabalin or known hypersensitivity to the study drug.
- Uncontrolled concurrent 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01450163
Start Date
August 1 2011
End Date
December 1 2014
Last Update
May 9 2017
Active Locations (1)
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1
Instituto do Câncer do Estado de São Paulo ICESP
São Paulo, Brazil, 01246-000