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Acute Pain Caused by Paclitaxel in Patients With Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2009
First Received: March 10, 2009   Last Updated: May 1, 2009   History of Changes
Sponsors and Collaborators: North Central Cancer Treatment Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00860041
  Purpose

RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.

PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.


Condition Intervention
Cancer-Related Problem/Condition
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Drug: paclitaxel
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: assessment of therapy complications

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Observational
Official Title: Paclitaxel-Associated Acute Pain Syndrome Natural History Study

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum of the average pain score [ Designated as safety issue: No ]
  • Area under the curve of worst, average, and least pain [ Designated as safety issue: No ]
  • Development of new aches/pains attributed to paclitaxel [ Designated as safety issue: No ]
  • Worst pain reported for the overall week [ Designated as safety issue: No ]
  • Rate of non-prescription pain medication use [ Designated as safety issue: No ]
  • Rate of opioid use [ Designated as safety issue: No ]
  • Rate of other pain therapy use [ Designated as safety issue: No ]
  • Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores [ Designated as safety issue: No ]
  • Relationship between genetic biomarkers and the worst pain score [ Designated as safety issue: No ]
  • Differences between the results seen in the majority Caucasian population and the minority population (as a whole and broken down into Hispanic vs Black vs Asian vs Native American vs Pacific Islander) [ Designated as safety issue: No ]
  • Correlation of baseline pain, baseline analgesic intake, or baseline neuropathy symptoms with the eventual development of paclitaxel-associated acute pain syndrome or neuropathy [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2009
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
  • To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.
  • To perform a genotype-phenotype correlation study to identify genetic biomarkers that may contribute to the variation observed in paclitaxel-related toxicity using top candidate single nucleotide polymorphisms (SNPs) from a genome-wide SNP association study of 300 human lymphoblastoid cell lines.
  • To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).
  • To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.

OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).

Patients complete pain questionnaires at baseline, periodically during treatment with paclitaxel, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer
  • Planning to receive paclitaxel (excluding paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]) according to one of the following dosing schedules:

    • At least 175 mg/m^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively)
    • 70-90 mg/m^2 weekly (3 out of 4 weeks allowed; 4 weeks will be considered 1 course in this situation)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy > 6 months
  • Able to complete questionnaires (alone or with assistance)
  • Willing to provide required biological specimens
  • No prior or concurrent peripheral neuropathy (from diabetes or other causes)
  • No prior or concurrent fibromyalgia

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones
  • No concurrent neutrophil colony-stimulating factor therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860041

  Show 200 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000631962, NCCTG-N08C1
Study First Received: March 10, 2009
Last Updated: May 1, 2009
ClinicalTrials.gov Identifier: NCT00860041     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
pain
neurotoxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Neurotoxicity Syndromes
Paclitaxel
Tubulin Modulators
Pain
Antimitotic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Paclitaxel
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009