Trial Information

Paclitaxel-Associated Acute Pain Syndrome Natural History Study

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).

- Group I: Patients complete pain questionnaires at baseline, 2-8 days after each weekly
paclitaxel treatment given in combination with a neurotoxic agent, 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.

- Group II (closed to accrual as of 12/4/2009): Patients complete pain questionnaires at
baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with
a neurotoxic agent, 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.

- Group III (closed to accrual for general population, but remains open to minority
accrual only as of 8/7/2009): Patients complete pain questionnaires at baseline, 2-8
days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic
agent, 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.

- Group IV: Patients complete pain questionnaires at baseline, 2-8 days after each 2-4
week paclitaxel treatment not given in combination with a neurotoxic agent, 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.