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

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ClinicalTrials.gov Identifier: NCT03585673
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital

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.

Condition or disease Intervention/treatment Phase
Esophagus Squamous Cell Carcinoma (SCC) Metastatic Cancer Drug: Docetaxel-PM Drug: Oxaliplatin Phase 2

Detailed Description:

Few results directly study the combination of docetaxel and oxaliplatin in the squamous cell cancer of the esophagus, but some studies have shown that it is safe to In the phase II study for the patients with gastroesophageal junction adenocarcinoma, a prior study reported the efficacy and safety of the combination therapy of docetaxel 80mg/m2 and oxaliplatin 100mg/m2 every 3 weeks schedule. Entire response rate was 34% and median survival duration was 11.6 months. Over grades 3 anemia and neutropenia were found in 17%, respectively, and non-hematological toxicities were mostly mild to moderate. In this study, a five-day preventive granulocyte colony-stimulating factor (G-CSF) was used to reduce hematology toxicity.

Meanwhile, there was the phase I/II studies of added capecitabine to docetaxel and oxaliplatin with divided schedule d1 and d8 every 3weeks for reducing toxicities. The subjects who participated in this study had at least one previous history of chemotherapy, but overall response rates were 43% and median values for the entire duration of survival were 9.8months. However, the side effects were significant, with 30 % of patients seeing diarrhea of Grade 3 or higher and 17 % seeing infection of Grade 3 or higher (SAE) reported at 37 %.

Looking at the reasons and background for this, the effects of docetaxel on esophageal squamous cell cancer patients are already known, and weekly divided administration has also demonstrated a reasonable level of effectiveness and safety. In studies conducted on gastric and esophageal adenocarcinoma, the combination of docetaxel and oxaliplatin also showed reasonable levels of effects and side effects.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Docetaxel-PM + Oxaliplatin D1,8 every 3weeks until progression
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel-polymeric Micelles(PM) Plus Oxaliplatin as a First-line Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Docetaxel-PM+Oxaliplatin
  • Docetaxel-PM 35mg/m2 D1, 8 I.V.
  • Oxaliplatin 120mg/m2 D1 I.V. Every 3 weeks till progression
Drug: Docetaxel-PM
Docetaxel-PM 35mg/m2 intravenous over 1hour day1 and 8 every 3 weeks till progression
Other Name: NANOXEL-M

Drug: Oxaliplatin
Oxaliplatin 120mg/m2 intravenous over 2 hour day 1 every 3 weeks till progression
Other Name: NEXATIN




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: up to 6 months ]
    complete response + partial response by RECIST


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: up to 12 months ]
    progression or death

  2. Overall survival [ Time Frame: up to 12 months ]
    death event

  3. Adverse event [ Time Frame: up tp 12 months ]
    Hypersensitivity or any side effects by NCI-Common Terminology Criteria for Adverse Events (CTCAE) v4.03



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585673


Contacts
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Contact: Sung Yong Oh, MD +82512402808 drosy@dau.ac.kr

Locations
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Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Contact: Sung Yong Oh, MD    +82512402808    drosy@dau.ac.kr   
Contact: EunKyung Lee, RN    +82512405044    dongahicrc12@naver.com   
Sponsors and Collaborators
Sung Yong Oh
Investigators
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Principal Investigator: Sung Yong Oh, MD Dong-A University Hospital

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Responsible Party: Sung Yong Oh, Principal Investigator, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT03585673     History of Changes
Other Study ID Numbers: DAUHIRB-18-041
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sung Yong Oh, Dong-A University Hospital:
esophageal cancer
metastatic
inoperable
relapsed
Additional relevant MeSH terms:
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Oxaliplatin
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action