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

• 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.
  
  

• 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
  
  

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.