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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471470
Recruitment Status : Active, not recruiting
First Posted : November 15, 2011
Last Update Posted : January 11, 2018
Roche Pharma AG
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
Actual Study Start Date : July 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: neoadjuvant Drug: 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)

Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: Up to 4 weeks after surgery ]
    R0 resection means complete resection of tumor.

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 3 years ]
    Overall survival will be measured from the start of study treatment to documented death of any cause.

  2. Angiogenetic biomarkers [ Time Frame: Baseline and 6 weeks after treatment ]
    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

  3. Progression-free survival [ Time Frame: Up to 3 years ]
    Time to progression will be measured from the start of study treatment to documented tumor progression.

  4. Toxicity [ Time Frame: Up to 6 months ]
    Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • 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

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 identifier (NCT number): NCT01471470

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Roche Pharma AG
Principal Investigator: Yoon-Koo Kang, MD, PhD Asan Medical Center

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center Identifier: NCT01471470     History of Changes
Other Study ID Numbers: AMC ONCGI-1003
First Posted: November 15, 2011    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: July 2017

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Advanced gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic