Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel

• Number of patients benefit of pregabalin on paclitaxel-induced peripheral neuropathy at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ] [ Designated as safety issue: No ]
• Number of toxicities related to pregabalin therapy in this study situation at 6 months. [ Time Frame: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment ] [ Designated as safety issue: No ]

This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.

PRIMARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on pain related to paclitaxel-associated acute pain syndrome (P-APS). SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible effect of pregabalin on paclitaxel-induced peripheral neuropathy. II. To obtain pilot data regarding the possible relative toxicities related to pregabalin therapy in this study situation. TERTIARY OBJECTIVES: I. To characterize neurological testing abnormalities that might occur with the P-APS, and to evaluate neurological testing abnormalities during the period of the longer-term chemotherapy-induced peripheral neuropathy (CIPN). II. To determine the PRO incidence and characteristics of, and change in, P-APS and paclitaxel induced more chronic CIPN over several cycles. These data will serve to confirm the results obtained in our previous natural history study N08C1. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pregabalin orally (PO) twice daily (BID), beginning on the first night of chemotherapy, for 12 weeks and then once daily (QD) for 1 week. ARM II: Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week. After completion of study treatment, patients are followed up every 30 days for 6 months.

• Pain
• Peripheral Neuropathy

• Drug: pregabalin
  Given PO
  Other Names:

  • 3-Isobutyl GABA
  • CI-1008
  • Lyrica
  • PD-144723
• Drug: placebo
  Given PO
  Other Name: PLCB
• Other: questionnaire administration
  Ancillary studies

• Experimental: Arm I (pain therapy)
  Patients receive pregabalin PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
  Interventions:

  • Drug: pregabalin
  • Other: questionnaire administration
• Placebo Comparator: Arm II (placebo)
  Patients receive placebo PO BID, beginning on the first night of chemotherapy, for 12 weeks and then QD for 1 week.
  Interventions:

  • Drug: placebo
  • Other: questionnaire administration

Inclusion Criteria:

• Age > or equal to 18 years
• Ability to complete questionnaires by themselves or with assistance Paclitaxel at a dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of 12 weeks without any other concurrent therapy
• Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or neo-adjuvant) setting, every week for a planned course of 12 weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors).
• Life expectancy > 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for women of childbearing potential only (per clinician discretion)

Exclusion Criteria:

• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception since this study involves agents that have known genotoxic, mutagenic and teratogenic effects
• Previous diagnosis of diabetic or other peripheral neuropathy
• Current, planned or previous use, within last 6 months, of gabapentin or pregabalin
• History of allergic or other adverse reactions to gabapentin or pregabalin
• Significant renal insufficiency with a history of a creatinine clearance (CrCL) < 30ml/min
• Prior exposure to neurotoxic chemotherapy
• Seizure history
• Diagnosis of fibromyalgia
• Previous exposure to paclitaxel