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

• Status: Unknown status
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sung Yong Oh
• Treatments: Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

1. A patient whose squamous cell cancer of the esophagus or esophago-gastric junction has been confirmed by biopsy or cytology.

2. A patient who is not subject to local treatment such as surgical excision or concurrent definitive chemoradiotherapy.

3. Metastatic or relapsed esophageal cancer patients who planned first line palliative treatment.

4. Patients' age over 18

5. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2

6. Patient has measurable lesions with RECIST v1.1

7. 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)

8. Patients with at least three months of an expected life.

9. Signing written consent from patients or their legal guardians and understanding the right to withdraw consent at any time without disadvantage.

Exclusion Criteria:

1. 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

2. Patients with a history of administration of docetaxel, paclitaxel, or oxaliplatin at any time in the past.

3. 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).

4. The clinically confirmed esophagus obstruction, gastrointestinal bleeding, or perforation (except if the symptoms are sufficiently controlled through proper procedures such as stents).

5. Patients with significant, uncontrolled cardiovascular disease, infection, or infectious fever.

6. Patients with uncontrolled brain metastasis.

7. 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.

8. Patients with pregnancy, breast feeding, or future plans.

9. Because of uncontrolled diabetes or diabetic neuropathy, patients who have any subjective symptoms regardless of their degree

10. Patients who have taken antihistamine or steroid within four weeks of clinical trial treatment

11. In combination with the state of Docetaxel-PM, patients who are not permitted to take combined medication (patients with severe renal dysfunction, para-platin, platinum compound, patients who have hypersensitivity to mannitol, etc.)

12. Patients with hypersensitivity history of Polysorbate 80

13. A patient who has hypersensitivity history to Docetaxel-PM or oxaliplatin or any drug containing platinum.

14. Patients with peripheral sensory neuropathy with functional impairment (may aggravate peripheral neuropathy) prior to clinical trial

15. Other cases

• Have experienced an infection or other serious medical problems that could cause damage to a patient's functions, making it difficult for the patient to receive treatment in a research plan.

• Mental, neurological, or dementia that can prevent a person from understanding and submitting a written statement and consent form

• Patients who are certain to be out of the clinical trial or who cannot be monitored regularly for the following reasons: For example, psychological, social, family or geographical reasons, or conditions that make it difficult to observe or comply with appropriate clinical trial plans.

• Uncontrolled hepatitis and chronic liver disease

• Other patients who are judged unfit for clinical trials by their physicians and researchers