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A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Advanced Gastric Cancer

Thank you

Trial Information

A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

R0 resection rate

Outcome Description:

R0 resection means complete resection of tumor.

Outcome Time Frame:

Up to 4 weeks after surgery

Safety Issue:

No

Principal Investigator

Min-Hee Ryu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

Korea: Food and Drug Administration

Study ID:

AMC ONCGI-1003

NCT ID:

NCT01471470

Start Date:

July 2010

Completion Date:

December 2014

Related Keywords:

  • Advanced Gastric Cancer
  • Advanced gastric cancer
  • Neoadjuvant
  • Bevacizumab
  • Stomach Neoplasms

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