A Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Overview
- Phase
- Phase 2
- Intervention
- irinotecan hydrochloride
- Conditions
- Adenocarcinoma of the Gastroesophageal Junction
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Time to progression, evaluated using RECIST
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: I. Determine the efficacy of irinotecan, cisplatin, and bevacizumab, in terms of time to progression, in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. SECONDARY OBJECTIVES: I. Determine other measures of efficacy, including response rate and median and 1-year survival, in patients treated with this regimen. II. Determine the toxicity of this regimen in these patients. III. Correlate CT perfusion imaging results with the efficacy of this regimen, in terms of time to progression, objective response, and survival, in these patients. IV. Determine the feasibility of serial serum proteomic assays in predicting response to therapy, in terms of time to progression, objective response, and survival, in patients treated with this regimen. V. To bank paraffin stored tumor biopsy material for future planned immunohistochemistry studies to correlate with sensitivity to bevacizumab based combination chemotherapy. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: irinotecan hydrochloride
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: bevacizumab
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: cisplatin
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: computed tomography
Treatment (bevacizumab, cisplatin, irinotecan)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive cisplatin IV over 30 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Time to progression, evaluated using RECIST
Time Frame: Up to 1 year
Kaplan-Meier estimates will be used.
Secondary Outcomes
- Incidence of toxicity, evaluated using CTCAE version 3.0(Up to 1 year)
- Overall response rate, evaluated using RECIST(Up to 1 year)
- Complete response rate, evaluated using RECIST(Up to 1 year)
- Duration of response, evaluated using RECIST(From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 1 year)
- Survival(Up to 1 year)