Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer

NCT00380874

Last updated date
Study Location
Pfizer Investigational Site
St. Leonards, New South Wales, 2065, Australia
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chemotherapy-Induced Peripheral Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or metastatic Colorectal Cancer (Dukes D)

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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


- Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA
or pregabalin according to the respective local labeling

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Chemotherapy-Induced Peripheral NeuropathyPrevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer NCT00380874
  1. St. Leonards, New South Wales
  2. Adelaide, South Australia
  3. Bielefeld,
  4. Essen,
  5. Hamm,
  6. Chieti Scalo,
  7. Potenza,
  8. Goyang-si, Gyeonggi-do
  9. Seoul,
  10. Seoul,
  11. Santander, Cantabria
  12. Alicante,
  13. Jaen,
  14. Niao-Sung Hsiang, Kaohsiung Hsien
  15. Taipei,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy In Subjects With Advanced Colorectal Cancer
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer
Brief Summary Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.
Detailed Description This study was terminated on July 15, 2008. The results of an interim analysis showed that the conditional power to detect a difference in treatment groups was insufficient to warrant study continuation and therefore termination of the trial was recommended. The decision to terminate the trial was not based on safety concerns.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy-Induced Peripheral Neuropathy
Intervention  ICMJE
  • Drug: Pregabalin
    150- 600 mg/day (double blind in divided doses)
    Other Name: Chemotherapy
  • Drug: Placebo
    Placebo
    Other Name: Chemotherapy
Study Arms  ICMJE
  • Experimental: 1
    flexible dosing
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 10, 2009)
64
Original Enrollment  ICMJE
 (submitted: September 25, 2006)
200
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of cytological confirmed carcinoma of the Colon Stage III (Dukes C) or metastatic Colorectal Cancer (Dukes D)
  • 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

Exclusion Criteria:

  • 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
  • Any patients who are not suitable to be treated with either Oxaliplatin and/or 5-FU/FA or pregabalin according to the respective local labeling
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Italy,   Korea, Republic of,   Spain,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380874
Other Study ID Numbers  ICMJE A0081124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP