Clinical trial NCT01471470: Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
Official title: A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Keywords: Advanced gastric cancer
Neoadjuvant
Bevacizumab
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2011-11-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: R0 resection rate
timeFrame: Up to 4 weeks after surgery
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 3 years
measure: Progression-free survival
timeFrame: Up to 3 years
measure: Adverse Event
timeFrame: Up to 28 days after end of treatment
measure: Angiogenetic biomarkers
timeFrame: Baseline and 6 weeks after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Yoon-Koo Kang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: