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

The Ohio State University

Status and phase: Withdrawn; Phase 1

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Digestive System Carcinoma; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Chemotherapy-Induced Peripheral Neuropathy

Treatments: Drug: Lorcaserin Hydrochloride; Drug: Lorcaserin; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04205071

OSU-19085

P30CA016058 (U.S. NIH Grant/Contract)

NCI-2019-03368 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment (lorcaserin)

Experimental group

Description:

Patients receive lorcaserin PO on day 1. The starting dose of lorcaserin will be 10 mg.

Treatment:

Drug: Lorcaserin

Other: Questionnaire Administration

Drug: Lorcaserin Hydrochloride