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

NCT00380874 | Terminated Phase 4 Results DMC

• 1 other identifier: A0081124
• Study Type: interventional
• Target: 64
• Locations: 6 countries
• Sites: 15

Brief Summary

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

Conditions

Chemotherapy-Induced Peripheral Neuropathy

Keywords

Pain; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration Adjusted Average Change (DAAC) of Paresthesic Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)

  Baseline to Cycle 9

• Duration Adjusted Average Change (DAAC) of Dysesthesia Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)

  Baseline to Cycle 9, LOCF cycle endpoint

• Duration Adjusted Average Change (DAAC) of Pain Symptom Score Within Each Cycle of Chemotherapy Measured by Numeric Rating Scale (NRS)

  Baseline to Cycle 9, LOCF cycle endpoint

• Change in Pain Scores Rated on Neuropathic Pain Symptom Inventory (NPSI) Subscales From Baseline Cycle

  Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint

• Number of Participants With Persistent Paresthesic, Dysesthesic, and Pain Symptoms

  Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint

Study Arms (2)

1

EXPERIMENTAL

flexible dosing

Drug: Pregabalin

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin DRUG

150- 600 mg/day (double blind in divided doses)

Also known as: Chemotherapy

1

Placebo DRUG

Placebo

Also known as: Chemotherapy

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (15)

Pfizer Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Pfizer Investigational Site

Adelaide, South Australia, 5000, Australia

Location

Pfizer Investigational Site

Bielefeld, 33611, Germany

Location

Pfizer Investigational Site

Essen, 45122, Germany

Location

Pfizer Investigational Site

Hamm, 59071, Germany

Location

Pfizer Investigational Site

Chieti Scalo, 66013, Italy

Location

Pfizer Investigational Site

Potenza, 85100, Italy

Location

Pfizer Investigational Site

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

Pfizer Investigational Site

Seoul, 130-702, South Korea

Location

Pfizer Investigational Site

Seoul, 137-701, South Korea

Location

Pfizer Investigational Site

Santander, Cantabria, 39008, Spain

Location

Pfizer Investigational Site

Alicante, 03010, Spain

Location

Pfizer Investigational Site

Jaén, 23007, Spain

Location

Pfizer Investigational Site

Niao-Sung Hsiang, Kaohsiung Hsien, Taiwan

Location

Pfizer Investigational Site

Taipei, 10449, Taiwan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain

Interventions

Pregabalin; Drug Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Therapeutics

Limitations and Caveats

Due to lack of symptom emergence, enrollment was halted, and endpoint modified because primary assumptions upon which it was powered (emergence of symptomatology) were not met, and not all endpoints were able to be reliably analyzed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: January 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 11, 2021
• Results First Posted: April 17, 2009

Record last verified: 2009-10

Locations

TW (2); IT (2); DE (3); KR (3); AU (2); ES (3)