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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Vanderbilt-Ingram Cancer Center

Current Primary Outcome: Change in urinary PGE-M level after paclitaxel treatment [ Time Frame: Day 1 before paclitaxel treatment and day 4, after treatment ]

Change in amount of PGE-M in the urine from before administration of paclitaxel to 4 days after treatment.


Original Primary Outcome: Relationships among paclitaxel dose, prostaglandin production, and patient-reported pain

Current Secondary Outcome:

  • Correlation of change in urinary PEG-M level and paclitaxel dose [ Time Frame: Day 1 before paclitaxel treatment and day 4, after treatment ]
    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 ]
    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 ]
    Inter-relationship be the level of urinary luekotriene E_4 from before treatment compared to day 4 after paclitaxel treatment


Original Secondary Outcome:

Information By: Vanderbilt-Ingram Cancer Center

Dates:
Date Received: March 30, 2010
Date Started: November 2009
Date Completion:
Last Updated: April 1, 2013
Last Verified: March 2013