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Esophagus Squamous Cell Carcinoma (SCC)Phase 2DOSENCT03585673

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

A Phase 2 study testing Docetaxel-PM and Oxaliplatin in people with Esophagus Squamous Cell Carcinoma (SCC) and Metastatic Cancer, run by Sung Yong Oh at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Docetaxel-PM and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteSouth Korea
Study dates
1 Jun 2018to 30 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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
  • 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.)
  • Patients with hypersensitivity history of Polysorbate 80
  • A patient who has hypersensitivity history to Docetaxel-PM or oxaliplatin or any drug containing platinum.
  • Patients with peripheral sensory neuropathy with functional impairment (may aggravate peripheral neuropathy) prior to clinical trial
  • 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

Trial locations and contacts

1 site in 1 country.

Sung Yong Oh, MD contact

+82512402808

drosy@dau.ac.kr

South Korea1 site, 1 recruiting

  • Dong-A University Hospital

    Busan, 49201

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

    EunKyung Lee, RN, +82512405044, dongahicrc12@naver.com

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Docetaxel-PM, Oxaliplatin
Keywords
esophageal cancer, metastatic, inoperable, relapsed
Medical subject headings
Esophageal Squamous Cell Carcinoma, Neoplasm Metastasis, Esophageal Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docetaxel-PMDrug

    Also called NANOXEL-M

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

  • OxaliplatinDrug

    Also called NEXATIN

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

Study groups in NCT03585673
Study groupRoleWhat they receive
Docetaxel-PM+OxaliplatinExperimental* Docetaxel-PM 35mg/m2 D1, 8 I.V. * Oxaliplatin 120mg/m2 D1 I.V. Every 3 weeks till progression
Receives: Drug: Docetaxel-PM; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    complete response + partial response by RECIST

    Measured: up to 6 months

Secondary outcomes (3)

  1. Progression free survival

    progression or death

    Measured: up to 12 months

  2. Overall survival

    death event

    Measured: up to 12 months

  3. Adverse event

    Hypersensitivity or any side effects by NCI-Common Terminology Criteria for Adverse Events (CTCAE) v4.03

    Measured: up tp 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2018
  2. Study start1 Jun 2018
  3. Primary completion30 Mar 2020 (estimated)
  4. Study completion30 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Docetaxel-PM + Oxaliplatin D1,8 every 3weeks until progression
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03585673
Sponsor's protocol ID
DAUHIRB-18-041
Acronym
DOSE
Status last verified
Jul 2018
First submitted
1 Jul 2018
Last updated
17 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel-PM and Oxaliplatin in people with Esophagus Squamous Cell Carcinoma (SCC) and Metastatic Cancer, run by Sung Yong Oh at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sung Yong Oh, MD (+82512402808, drosy@dau.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03585673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.

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