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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01471470
First received: July 18, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Advanced Gastric Cancer
Drug: Docetaxel, Capecitabine, Cisplatin, Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • R0 resection rate [ Time Frame: Up to 4 weeks after surgery ] [ Designated as safety issue: No ]
    R0 resection means complete resection of tumor.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Overall survival will be measured from the start of study treatment to documented death of any cause.

  • Angiogenetic biomarkers [ Time Frame: Baseline and 6 weeks after treatment ] [ Designated as safety issue: No ]
    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

  • Progression-free survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Time to progression will be measured from the start of study treatment to documented tumor progression.

  • Toxicity [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Treatment toxicities are evaluated according to the NCI common toxicity criteria version 3.0


Estimated Enrollment: 31
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471470

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

No publications provided

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01471470     History of Changes
Other Study ID Numbers: AMC ONCGI-1003
Study First Received: July 18, 2011
Last Updated: August 5, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Advanced gastric cancer
Neoadjuvant
Bevacizumab

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Bevacizumab
Docetaxel
Capecitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing 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
Antimetabolites

ClinicalTrials.gov processed this record on September 16, 2014