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
|Condition or disease||Intervention/treatment||Phase|
|Esophagus Squamous Cell Carcinoma (SCC) Metastatic Cancer||Drug: Docetaxel-PM Drug: Oxaliplatin||Phase 2|
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.
|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)|
|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|
Docetaxel-PM 35mg/m2 intravenous over 1hour day1 and 8 every 3 weeks till progression
Other Name: NANOXEL-M
Oxaliplatin 120mg/m2 intravenous over 2 hour day 1 every 3 weeks till progression
Other Name: NEXATIN
- Overall response rate [ Time Frame: up to 6 months ]complete response + partial response by RECIST
- Progression free survival [ Time Frame: up to 12 months ]progression or death
- Overall survival [ Time Frame: up to 12 months ]death event
- Adverse event [ Time Frame: up tp 12 months ]Hypersensitivity or any side effects by NCI-Common Terminology Criteria for Adverse Events (CTCAE) v4.03
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
|Contact: Sung Yong Oh, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Dong-A University Hospital||Recruiting|
|Busan, Korea, Republic of, 49201|
|Contact: Sung Yong Oh, MD +82512402808 email@example.com|
|Contact: EunKyung Lee, RN +82512405044 firstname.lastname@example.org|
|Principal Investigator:||Sung Yong Oh, MD||Dong-A University Hospital|