Lorcaserin in Treating Chemotherapy-Induced Peripheral Neuropathy in Patients With Stage I-IV Gastrointestinal or Breast Cancer

Pilot Trial of Acute Effect of Lorcaserin to Reduce Patient-Reported Symptoms of Taxane- and Oxaliplatin-Induced Peripheral Neuropathy

This phase I trial studies how well lorcaserin works in treating chemotherapy-induced peripheral neuropathy in patients with stage I-IV gastrointestinal or breast cancer. Chemotherapy-induced peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. This condition can occur in patients who have received taxane chemotherapy drugs, or the chemotherapy drug oxaliplatin. Lorcaserin may improve chemotherapy-induced peripheral neuropathy by reducing pain, preventing or relieving joint symptoms, and improving balance.

PRIMARY OBJECTIVES:

I. To evaluate preliminary efficacy of lorcaserin to improve balance decrements in patients with chronic chemotherapy-induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. To evaluate patient reported outcomes (PROs) after a one time dose of lorcaserin in patients with chronic CIPN.

OUTLINE:

Patients receive lorcaserin orally (PO) on day 1.

After completion of study treatment, patients are followed for 4 weeks.

Inclusion Criteria:

• Patient with known diagnosis of gastrointestinal (GI) cancer or breast cancer stages I-IV
• Prior exposure to paclitaxel or oxaliplatin within last 24 months
• Have symptomatic CIPN confirmed by self-report, as demonstrated by PRO measure, CIPN-20
• If a female subject is with child bearing potential, she must have a negative pregnancy test at screening
• Female subjects of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 3 months after completion of study treatment administration. Adequate contraception includes methods such as oral contraceptives, double barrier method (condom plus spermicide or diaphragm), or abstaining from sexual intercourse
• Be willing and able to understand and sign the written informed consent document

Exclusion Criteria:

• Is beyond 24 months out from completion of oxaliplatin or paclitaxel
• Is asymptomatic for CIPN
• Is currently pregnant or breast feeding as there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lorcaserin
• Has any other medical or psychiatric condition that in the opinion of the investigator would make the study therapy unsafe for the patient