A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THEPREVENTION AND TREATMENT OF CHEMOTHERAPY-INDUCED PERIPHERALNEUROPATHY SYMPTOMS WITH PREGABALIN IN SUBJECTS WITH ADVANCED COLORECTAL CANCER - na
- Conditions
- CHEMOTHERAPY-INDUCED PERIPHERAL NEUROPATHY SYMPTOMSMedDRA version: 8.1Level: LLTClassification code 10029331Term: Neuropathy peripheral
- Registration Number
- EUCTR2006-002917-11-DE
- Lead Sponsor
- Pfizer Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Male or female patients between 18-80 years of age
2. Females of childbearing potential must have a negative serum ß-HCG pregnancy test and be practicing an effective form of contraception. Complete abstinence may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any screening tests or procedures for the study.
3. A confirmed diagnosis of Colorectal Cancer
4. Independent of this protocol, the patient has decided to receive standard of care for the treatment of cancer with oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA) for a minimum of 9 cycles
5. The patient has a performance status score of 0-2 (inclusive) as measured by the ECOG Performance Scale.
6. NRS (Numeric Rating) score = 0 for paresthesia, dysesthesia
7. Signed and dated informed consent will be obtained from each subject (only include those able to consent) in accordance with the local regulatory and legal requirements
8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Subjects who are willing, but need assistance for self administered questionnaires may be considered acceptable, but must first be discussed on a caseby- case basis with the Pfizer monitor prior to any screening tests or procedures for the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnant or lactating women, or women of childbearing potential not practicing an effective method of contraception
2. Any treatment with previous chemotherapeutic agents with neuropathic effects. Refer to appendix M.
3. Any history of known brain metastases, spinal cord compression, or evidence of symptomatic brain or leptomeningeal carcinomatosis
4. Presence of neuropathic pain or peripheral polyneuropathy or identified causes of painful paresthesia including radiotherapy-induced or malignant plexopathy, lumbar or cervical radiculopathy existing prior to baseline
5. A current medical diagnosis that could potentially lead to the development of neuropathic pain over the course of the study (e.g. HIV neuropathy, herpes zoster) or pre-existing peripheral neuropathy of another etiology, including: (e.g. B12 deficiency, AIDS, monoclonal gammopathy,diabetes, heavy metal poisoning, amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy)
6. A diagnosis of dihydro-pyrimidine-dehydrogenase (DPD) deficiency prior to baseline
7. A medical diagnosis of renal failure prior to baseline
8. History of neoplasm other than colorectal carcinoma that could potentially lead to previous neuropathic pain. Subjects with previous histories of neoplasms may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to randomization in the study, except for: radically treated non melanoma skin cancer or in situ carcinoma of cervix.
9. Recent history of myocardial infarction within 6 months from study entry, uncontrolled hypertension or high risk uncontrolled arrhythmias, unstable angina pectoris
10. A previous history of intolerance or hypersensitivity to pregabalin, gabapentin, or other drugs structurally similar to the neurotransmitter GABA
11. Creatinine Clearance <60 mL/min (from serum creatinine).
12. Hematological values: WBC < 2.5 X 103/µl ; Platelets < 100 X 103/µl at screening
13. Clinically significant abnormal 12-lead electrocardiogram (ECG).
14. Abuse of illicit drugs or alcohol within the past 2 years
15. In the judgment of the investigator the subject is unable or unlikely to follow the protocol, or otherwise might not be suitable for the study
16. In the judgment of the investigator, any subject unable to understand the nature, scope, procedures and possible consequences of the study and/or evidence of an uncooperative attitude
17. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
18. Previous use of gabapentin or pregabalin within 30 days prior to randomization or likelihood of engaging in these treatments during the study period
19. Subjects taking the following concomitant medications:
= One month stable doses of TCAs, antidepressants, paracetamol,
= 2 weeks stable doses corticosteroids, NSAIDs,
= One month stable use of hypnotics/sedatives such as zopiclone, eszopiclone, ketazolam, zolpidem, zaleplon, triazolam, Dosing frequency of 3-7 times/ week is considered stable,
= One month stable use of benzodiazepines such as alprazolam, clonazepam, diazepam, flurazepam, lorazepam, midazolam, quazepam, triazolam, and temazepam. Medications initiated as standard treatment with chemotherapy will be considered stable at non-flucuating dosages during the trial.
20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method