Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving Paclitaxel

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jill Gilbert, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01096407
First received: March 30, 2010
Last updated: April 1, 2013
Last verified: March 2013
  Purpose

RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain.

PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel.


Condition Intervention Phase
Arthralgia
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: assessment of therapy complications
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Change in urinary PGE-M level after paclitaxel treatment [ Time Frame: Day 1 before paclitaxel treatment and day 4, after treatment ] [ Designated as safety issue: No ]
    Change in amount of PGE-M in the urine from before administration of paclitaxel to 4 days after treatment.


Secondary Outcome Measures:
  • Correlation of change in urinary PEG-M level and paclitaxel dose [ Time Frame: Day 1 before paclitaxel treatment and day 4, after treatment ] [ Designated as safety issue: No ]
    Inter-relationship between the dose of paclitaxel and the change in level of urinary PEG-M from before treatment compared to day 4 of paclitxel treatment

  • Correlation of urinary PEG-M level with pain [ Time Frame: day 1 before paclitaxel treatment and day 4, after treatment ] [ Designated as safety issue: No ]
    Inter-relationship between the level of urinary PEG-M level with level of pain, measured from before treatment compared to day 4 after paclitaxel treatment. Pain is measured on the Brief Pain Inventory (BPI). The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes). The summary score is the average of the 7 scores, with higher scores indicating greater interference with pain.

  • Change in urinary luekotriene E_4 level after paclitaxel treatment [ Time Frame: day 1 before paclitaxel treatment and day 4, after treatment ] [ Designated as safety issue: No ]
    Inter-relationship be the level of urinary luekotriene E_4 from before treatment compared to day 4 after paclitaxel treatment


Enrollment: 5
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Paclitaxel-Induced Myalgias/Arthralgias Other: laboratory biomarker analysis
Collection of urine samples
Other: questionnaire administration
Completion of questionnaires
Procedure: assessment of therapy complications
An assessment will be completed.

Detailed Description:

OBJECTIVES:

Primary

  • To determine the change in urinary prostaglandin E metabolite (PGE-M) level after paclitaxel treatment in patients with a variety of solid tumor malignancies.
  • To determine whether a change in PGE-M level correlates with paclitaxel dose.
  • To determine whether the change in urinary PGE-M level correlates with patient reporting of pain, as measured by a visual analog scale and the Brief Pain Inventory short form (BPI-SF).

Secondary

  • To determine whether leukotriene levels are affected by paclitaxel treatment.

OUTLINE: At baseline (prior to the first dose of paclitaxel), patients complete a questionnaire about their baseline pain symptoms (including the Brief Pain Inventory short form and the visual analog scale); cigarette smoking status and second-hand smoke exposure; and routine use of any pain medications (including NSAIDs, selective COX-2 inhibitors, and opioid analgesics), corticosteroids, or leukotriene antagonists (montelukast or zafirlukast). Patients also complete questionnaires about their pain daily on days 2-7 after paclitaxel administration.

Urine samples are collected at baseline for urinary prostaglandin E metabolite (PGE-M), urinary leukotriene E_4 (LTE_4), and urinary cotinine levels and on day 4 for urinary PGE-M and LTE_4 levels.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Cancer patients that will be treated with paclitaxel.

Criteria

DISEASE CHARACTERISTICS:

  • Solid malignancy of any type
  • Patients must be scheduled to receive their first dose of paclitaxel at Vanderbilt-Ingram Cancer Center

    • Any paclitaxel-containing regimen or dosing schedule is allowed

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Accessible for follow-up
  • Able to submit urine samples
  • Able to complete questionnaires

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096407

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Jill Gilbert, M.D. Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Jill Gilbert, MD, Associate Professor of Medicine; Director, Hematology/Oncology Fellowship Program; Section Chief, Solid Tumor Oncology; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01096407     History of Changes
Other Study ID Numbers: VICC SUPP 0928, P30CA068485, VU-VICC-SUPP-0928
Study First Received: March 30, 2010
Last Updated: April 1, 2013
Health Authority: United States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
pain
arthralgia
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014