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CompletedNCT01471470Updated Jan 7, 2020

Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer

A Phase 2 interventional study of Docetaxel, Capecitabine, Cisplatin, Bevacizumab in Advanced Gastric Cancer, sponsored by Asan Medical Center. Completed at 1 site in South Korea. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by Asan Medical Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jul 2010, registered Jul 2011).
Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and bevacizumab are effective in the treatment of unresectable advanced gastric cancer.

Read the detailed description

In our previous phase II study of neoadjuvant docetaxel, capecitabine and cisplatin chemotherapy, patients with unresectable gastric cancer because of invasion to adjacent organs or metastasis to para-aortic lymph nodes received benefit from neoadjuvant chemotherapy. Based on these results and reports that bevacizumab enhances response rate, we planned docetaxel, capecitabine, cisplatin, and bevacizumab as neoadjuvant chemotherapy for patients with local invasion or para-aortic node metastasis alone.

02

Conditions studied

  • Advanced Gastric Cancer

Keywords

  • Advanced gastric cancer
  • Neoadjuvant
  • Bevacizumab
03

In context

Lead sponsor

Asan Medical Center is the lead sponsor of 577 studies on the registry; 73 are open to participants now.

Browse Asan Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically documented adenocarcinoma of the stomach or gastroesophageal junction.
  • Invasion to adjacent organ (T4) proven by endoscopic ultrasonography (EUS) or presence of paraaortic lymph node metastasis by CT and PET(short-axis diameter > 1 cm showing hot uptake in PET scan).
  • Age 18-70 years old
  • ECOG performance status 0-2
  • Adequate hepatic function(serum bilirubin \<1.5mg/dl, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL)
  • Adequate renal function(serum creatinine \<1.5mg/dl)
  • Adequate bone marrow function (WBC ≥4000 cell/㎕ with ANC ≥1500 cell/㎕, platelet count ≥100,000 cell/㎕)
  • HER2 negative (HER2 immunohistochemistry 0 or 1+, immunohistochemistry 2+ but FISH negative)
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Other histologic type than adenocarcinoma
  • Metastasis in other sites than paraaortic lymph nodes, like in liver or peritoneum.
  • Presence or history of other cancers
  • History of prior chemotherapy, antiangiogenic agents, or radiation.
  • Patients with definite ascites in abdomen CT scan
  • Presence of not adequately controlled CNS metastasis
  • Bowel obstruction
  • Evidence of gastrointestinal bleeding
  • Other serious illness or medical conditions including hypertension uncontrolled by medication.
  • Pregnant or lactating women
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    neoadjuvant

    Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab

Interventions

  • DrugDocetaxel, Capecitabine, Cisplatin, Bevacizumab

    Drug pages: Docetaxel · Capecitabine · Cisplatin · Bevacizumab

    Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)

06

What researchers measure

Primary outcomes

  1. R0 resection rate

    R0 resection means complete resection of tumor.

    Time frame: Up to 4 weeks after surgery

Secondary outcomes

  1. Overall survival

    Overall survival will be measured from the start of study treatment to documented death of any cause.

    Time frame: Up to 3 years

  2. Progression-free survival

    Time to progression will be measured from the start of study treatment to documented tumor progression.

    Time frame: Up to 3 years

  3. Adverse Event

    Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0

    Time frame: Up to 28 days after end of treatment

  4. Angiogenetic biomarkers

    cluster of differentiation 31, microvessel density, platelet derived growth factor, vascular endothelial growth factor-A, vascular endothelial growth factor receptor-1, vascular endothelial growth factor receptor-2, Neuropilin 1 and phosphatidylinositol glycan anchor biosynthesis, class F

    Time frame: Baseline and 6 weeks after treatment

07

Study locations

1 site
  • Asan Medical Center
    Seoul, 138-736, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2010 to primary completion in Dec 2017, 89 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2011
First posted
Nov 15, 2011
StartActual
Jul 2010
Primary completionActual
Dec 2017
CompletionActual
Jul 2018
Last update
Jan 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01471470
Lead sponsor
Asan Medical Center
Collaborators
Roche Pharma AG
Responsible party
Yoon-Koo Kang (Professor, Asan Medical Center) — Principal investigator
First posted
Nov 15, 2011
Start date
Jul 2010
Primary completion
Dec 2017
Completion
Jul 2018
Last update
Jan 7, 2020

Study contacts

Yoon-Koo Kang, MD, PhD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Docetaxel · Capecitabine · Cisplatin · Bevacizumab

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