Docetaxel-polymeric Micelles(PM) and Oxaliplatin for Esophageal Carcinoma

NCT03585673 | Unknown Phase 2

• 1 other identifier: DAUHIRB-18-041
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal or esophageal-gastric junction squamous cell cancer has dismal prognosis. And still no promising chemotherapeutic drugs is existed. In this study, The investigators wanted to look at the effects and safety of first line docetaxel-PM and oxaliplatin weekly administration chemotherapy for the participants with inoperable or metastatic esophageal squamous cell carcinoma.

Conditions

Esophagus Squamous Cell Carcinoma (SCC); Metastatic Cancer

Keywords

esophageal cancer; metastatic; inoperable; relapsed

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  complete response + partial response by RECIST

  up to 6 months

Secondary Outcomes (3)

• Progression free survival

  up to 12 months

• Overall survival

  up to 12 months

• Adverse event

  up tp 12 months

Study Arms (1)

Docetaxel-PM+Oxaliplatin

EXPERIMENTAL

* Docetaxel-PM 35mg/m2 D1, 8 I.V. * Oxaliplatin 120mg/m2 D1 I.V. Every 3 weeks till progression

Drug: Docetaxel-PM; Drug: Oxaliplatin

Interventions

Docetaxel-PM DRUG

Docetaxel-PM 35mg/m2 intravenous over 1hour day1 and 8 every 3 weeks till progression

Also known as: NANOXEL-M

Docetaxel-PM+Oxaliplatin

Oxaliplatin DRUG

Oxaliplatin 120mg/m2 intravenous over 2 hour day 1 every 3 weeks till progression

Also known as: NEXATIN

Docetaxel-PM+Oxaliplatin

Eligibility Criteria

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

You may qualify if:

• A patient whose squamous cell cancer of the esophagus or esophago-gastric junction has been confirmed by biopsy or cytology.
• A patient who is not subject to local treatment such as surgical excision or concurrent definitive chemoradiotherapy.
• Metastatic or relapsed esophageal cancer patients who planned first line palliative treatment.
• Patients' age over 18
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2
• Patient has measurable lesions with RECIST v1.1
• Patients with appropriate organ functions, such as the following, within seven days prior to the start of a clinical trial
• Proper bone marrow function (ANC ≥ 1500/uL, Platelets ≥ 100,000/uL and Hb 8/microliter(uL))
• Proper kidney function (serum creatinine ≤ 1.5 mg/L, 24-hour urine test or creatinine clearance ≥ 60 ml/min based on Cockcroft-Gault formula)
• Appropriate liver function (bilirubin ≤ 1.5 mg/dL, transaminases aspartate transaminase (AST or SGOT) and alanine transaminase (AST or SGOT) ≤ 2.5 times normal upper limit)
• Patients with at least three months of an expected life.
• Signing written consent from patients or their legal guardians and understanding the right to withdraw consent at any time without disadvantage.

You may not qualify if:

• In the case that the following treatment has been received in the past for the local stage treatment more than 6 months from the end of the treatment, enrolment is allowed.
• Neoadjuvant chemotherapy
• Concurrent or sequential chemoradiotherapy
• Adjuvant chemotherapy
• Adjuvant concurrent or sequential chemoradiotherapy
• Definitive concurrent or sequential chemoradiotherapy
• Patients with a history of administration of docetaxel, paclitaxel, or oxaliplatin at any time in the past.
• Patients who have been treated for other active cancers other than esophageal cancer less than five years (but cured kin basal cell cancer or cured cervical carcinoma in situ are excluded).
• The clinically confirmed esophagus obstruction, gastrointestinal bleeding, or perforation (except if the symptoms are sufficiently controlled through proper procedures such as stents).
• Patients with significant, uncontrolled cardiovascular disease, infection, or infectious fever.
• Patients with uncontrolled brain metastasis.
• In the case of major surgery within the first two weeks of clinical trial treatment, the patient must recover sufficiently from the effects of this surgery.
• Patients with pregnancy, breast feeding, or future plans.
• Because of uncontrolled diabetes or diabetic neuropathy, patients who have any subjective symptoms regardless of their degree
• Patients who have taken antihistamine or steroid within four weeks of clinical trial treatment

Sponsors & Collaborators

• Sung Yong Oh: lead

Study Sites (1)

Dong-A University Hospital

Busan, 49201, South Korea

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Neoplasm Metastasis; Esophageal Neoplasms; Recurrence

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Sung Yong Oh, MD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Yong Oh, MD

CONTACT

+82512402808; drosy@dau.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Docetaxel-PM + Oxaliplatin D1,8 every 3weeks until progression

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 13, 2018
• Study Start: June 1, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2021
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)