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

NCT04205071 | Withdrawn Phase 1 DMC FDA Drug

• 3 other identifiers: OSU-19085NCI-2019-03368P30CA016058
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Measure the improvement in balance for patients with chronic CIPN

  Will be evaluated using a measure of postural control: root-mean-squared amplitude of center of pressure (COP) excursion for the medial-lateral axis of the body .

  Up to 4 weeks

Secondary Outcomes (1)

• Improvement in patient-reported chemotherapy-induced peripheral neuropathy symptoms

  Baseline up to 4 weeks

Other Outcomes (1)

• Nerve conduction test (NCT) result analysis

  Baseline up to 4 weeks

Study Arms (1)

Treatment (lorcaserin)

EXPERIMENTAL

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

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

Interventions

Lorcaserin DRUG

Given PO

Treatment (lorcaserin)

Lorcaserin Hydrochloride DRUG

Given PO

Also known as: LORCASERIN HYDROCHLORIDE ANHYDROUS

Treatment (lorcaserin)

Questionnaire Administration OTHER

Ancillary studies

Treatment (lorcaserin)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• The Jamesline

MeSH Terms

Interventions

lorcaserin

Study Officials

• Maryam B Lustberg, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: December 19, 2019
• Study Start: November 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share