Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Gastroesophageal Junction, Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Gastric Cancer, Stage IIIA Gastric Cancer, Stage IIIB Gastric Cancer, Stage IIIC Gastric Cancer, Stage IV Gastric Cancer
In brief
This phase II trial is studying how well giving irinotecan and cisplatin together with bevacizumab works in treating patients with unresectable or metastatic gastric (stomach) or gastroesophageal junction adenocarcinoma (cancer). Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving chemotherapy together with a monoclonal antibody may kill more tumor cells.
Key facts
- Study ID
- NCT00084604
- Run by
- National Cancer Institute (NCI)
- People needed
- 47
- Starts
- 2004-04-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma
- Metastatic or unresectable disease
- Siewert's classification I, II, or III
- No ulcerated, non-healing tumors or tumors that have developed a malignant fistula
- No esophageal tumors
- No known or active brain metastases
- Performance status - Karnofsky 60-100%
- Performance status - ECOG 0-2
- Neutrophil count >= 1,500/mm\^3
- Platelet count >= 75,000/mm\^3
- No bleeding diathesis or coagulopathy
- Bilirubin =< 1.5 mg/dL
- AST and ALT =< 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- PT (INR) =< 1.5
- PTT =< 3 seconds above ULN
- Creatinine =< 1.5 mg/dL
- Proteinuria < 1+
- Protein < 500 mg/24-hour urine collection
- No acute ischemia or significant conduction abnormality by EKG
- No clinically significant cardiovascular disease
- No uncontrolled hypertension (blood pressure > 160/90 mm Hg on medication)
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
- No transient ischemic attack within the past 6 months
- No cerebrovascular accident within the past 6 months
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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