Acute Pain Caused by Paclitaxel in Patients With Cancer

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 exome-sequencing analysis and identify genetic variants that predict
paclitaxel- induced peripheral neuropathy.

- 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).

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

DISEASE CHARACTERISTICS:

- Diagnosis of cancer

- Planning to receive paclitaxel IV (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)

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