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A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer


Phase 4
18 Years
80 Years
Not Enrolling
Both
Chemotherapy-Induced Peripheral Neuropathy

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Trial Information

A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)

Outcome Time Frame:

Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A0081124

NCT ID:

NCT00380874

Start Date:

January 2007

Completion Date:

March 2008

Related Keywords:

  • Chemotherapy-Induced Peripheral Neuropathy
  • Pain
  • chemotherapy
  • Colorectal Neoplasms
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

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