Assessment of Paclitaxel-Induced Neuropathy

Inclusion Criteria (Severe Toxicity Group):

- Diagnosis of cancer (including, but not limited to, breast and ovarian cancer)

- Females aged 18 and older

- History of grade 3 or higher peripheral neurotoxicity, any neuromotor, neurocortical,
or neurocerebellar toxicity, myalgias or arthralgias refractory to non-steroidal
anti-inflammatory drugs and steroids, ong-term persistence (> 6 months) of grade 2 or
higher peripheral neuropathy, or other unusually severe neurotoxicity approved for
inclusion in study by Principal Investigator after completion of paclitaxel
chemotherapy regimen or history of peripheral neuropathy that required treatment with
narcotics or grade 2 or higher peripheral neuropathy after only 1 to 2 doses of
paclitaxel.

Inclusion Criteria (Control Group):

- History of no neurotoxicity (grade 0) after completion of a standard
paclitaxel-containing chemotherapy regimen

- Females age 18 and older

- Matched to a specified subject with neurotoxicity based on age (within 10 years),
tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity

Exclusion Criteria :

- Treatment with other severely neurotoxic chemotherapy (i.e. cisplatin) prior to or
concomitantly with paclitaxel. Carboplatin therapy is allowed.

- Presence of peripheral neuropathy prior to paclitaxel therapy

- Poorly controlled or insulin-dependent diabetes or other condition likely to
predispose to neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)