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

This study has been terminated.
(See detailed description for termination reason)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00380874
First received: September 25, 2006
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

Prevention and treatment of the severity of symptoms of chemotherapy-induced peripheral neuropathy.


Condition Intervention Phase
Chemotherapy-Induced Peripheral Neuropathy
Drug: Pregabalin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS) [ Time Frame: Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) [ Time Frame: Baseline to Cycle 9 ] [ Designated as safety issue: No ]
  • Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) [ Time Frame: Baseline to Cycle 9, LOCF cycle endpoint ] [ Designated as safety issue: No ]
  • Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS) [ Time Frame: Baseline to Cycle 9, LOCF cycle endpoint ] [ Designated as safety issue: No ]
  • Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle [ Time Frame: Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint ] [ Designated as safety issue: No ]
  • Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms [ Time Frame: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
flexible dosing
Drug: Pregabalin
150- 600 mg/day (double blind in divided doses)
Other Name: Chemotherapy
Placebo Comparator: 2 Drug: Placebo
Placebo
Other Name: Chemotherapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380874

Locations
Australia, New South Wales
Pfizer Investigational Site
St. Leonards, New South Wales, Australia, 2065
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Germany
Pfizer Investigational Site
Bielefeld, Germany, 33611
Pfizer Investigational Site
Essen, Germany, 45122
Pfizer Investigational Site
Hamm, Germany, 59071
Italy
Pfizer Investigational Site
Chieti Scalo, Italy, 66013
Pfizer Investigational Site
Potenza, Italy, 85100
Korea, Republic of
Pfizer Investigational Site
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
Pfizer Investigational Site
Seoul, Korea, Republic of, 130-702
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Spain
Pfizer Investigational Site
Santander, Cantabria, Spain, 39008
Pfizer Investigational Site
Alicante, Spain, 03010
Pfizer Investigational Site
Jaen, Spain, 23007
Taiwan
Pfizer Investigational Site
Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 10449
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00380874     History of Changes
Other Study ID Numbers: A0081124
Study First Received: September 25, 2006
Results First Received: March 10, 2009
Last Updated: October 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pain
chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014