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

Chemotherapy-Induced Peripheral Neuropathy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00380874
• Other study ID #: A0081124
• Status: Terminated
• Phase: Phase 4
• Start date: January 2007
• Est. completion date: March 2008

Study information

• Verified date: October 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Drug:
• Pregabalin
150- 600 mg/day (double blind in divided doses)
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	St. Leonards	New South Wales
Germany	Pfizer Investigational Site	Bielefeld
Germany	Pfizer Investigational Site	Essen
Germany	Pfizer Investigational Site	Hamm
Italy	Pfizer Investigational Site	Chieti Scalo
Italy	Pfizer Investigational Site	Potenza
Korea, Republic of	Pfizer Investigational Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Spain	Pfizer Investigational Site	Alicante
Spain	Pfizer Investigational Site	Jaen
Spain	Pfizer Investigational Site	Santander	Cantabria
Taiwan	Pfizer Investigational Site	Niao-Sung Hsiang	Kaohsiung Hsien
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Australia,  Germany,  Italy,  Korea, Republic of,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)	Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days).	Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
Secondary	Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)	Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).	Baseline to Cycle 9
Secondary	Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)	Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).	Baseline to Cycle 9, LOCF cycle endpoint
Secondary	Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)	Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days).	Baseline to Cycle 9, LOCF cycle endpoint
Secondary	Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle	Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours.	Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint
Secondary	Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms	Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime.	Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint

External Links

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