Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
This study is currently recruiting participants.
Verified January 2013 by Asan Medical Center
Sponsor:
Asan Medical Center
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: January 10, 2013
Last verified: January 2013
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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 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471470
Contacts
| Contact: Min-Hee Ryu | miniryu@amc.seoul.kr |
Locations
| Korea, Republic of | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
Sponsors and Collaborators
Asan Medical Center
Roche Pharma AG
Investigators
| Principal Investigator: | Min-Hee Ryu, 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: | January 10, 2013 |
| 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 Docetaxel Capecitabine Bevacizumab Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013