- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00084604
Irinotecan, Cisplatin, and Bevacizumab in Treating Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
A Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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
- No other arterial thromboembolic event within the past 6 months
- No New York Heart Association class II-IV congestive heart failure
- No serious cardiac dysrhythmia requiring medication
- No peripheral vascular disease (grade II or greater)
- No history of stroke
- No CNS disease within the past 5 years (e.g., uncontrolled seizures)
- No other concurrent uncontrolled illness
- No ongoing or active infection requiring parental antibiotics on Day 0 of study
- No serious, non-healing wound
- No serious wound healing by secondary intention
- No ulcer
- No bone fracture
- No psychiatric illness or social situation that would preclude study compliance
- No significant traumatic injury within the past 28 days
- No other neoplastic disease within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or nonmetastatic prostate cancer
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No other medical condition that would preclude study participation
Not pregnant or nursing
- No nursing during and for 4 months after study participation
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 4 months after study participation
- More than 8 weeks since prior immunotherapy and recovered
- No other concurrent biologic or immunologic agents
- No other concurrent bevacizumab
- No prior chemotherapy for metastatic disease
- No prior cisplatin or irinotecan
- Prior neoadjuvant and/or adjuvant chemotherapy or chemoradiotherapy allowed
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No other concurrent chemotherapy
- More than 3 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- More than 28 days since prior major surgical procedure or open biopsy
- More than 7 days since prior fine needle aspirations or core biopsies
- No concurrent major surgery
- No other concurrent investigational agents
- No other concurrent anticancer therapy
- No concurrent chronic daily aspirin (> 325 mg/day)
- No concurrent nonsteroidal anti-inflammatory medications that would inhibit platelet function at doses used to treat chronic inflammatory diseases
Full-dose anticoagulants allowed, provided the following criteria are met:
- INR in range (i.e., 2-3) while on a stable dose of warfarin or low molecular weight heparin
- No active bleeding or pathologic condition that would confer a high risk of bleeding (e.g., tumor involving major blood vessels or known varices)
- No concurrent thrombolytic agents
No concurrent vitamins, antioxidants, herbal preparations, or supplements
- Single tablet multivitamin allowed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Correlative studies
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Correlative studies
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to progression, evaluated using RECIST
Time Frame: Up to 1 year
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Kaplan-Meier estimates will be used.
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Up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate, evaluated using RECIST
Time Frame: Up to 1 year
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95% exact binomial confidence intervals will be used to describe the distribution.
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Up to 1 year
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Complete response rate, evaluated using RECIST
Time Frame: Up to 1 year
|
95% exact binomial confidence intervals will be used to describe the distribution.
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Up to 1 year
|
Duration of response, evaluated using RECIST
Time Frame: 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
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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
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Survival
Time Frame: Up to 1 year
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Kaplan-Meier estimates will be used.
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Up to 1 year
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Incidence of toxicity, evaluated using CTCAE version 3.0
Time Frame: Up to 1 year
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Up to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manisha Shah, Memorial Sloan Kettering Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Topoisomerase Inhibitors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Topoisomerase I Inhibitors
- Antibodies
- Immunoglobulins
- Bevacizumab
- Irinotecan
- Antibodies, Monoclonal
- Antineoplastic Agents, Immunological
Other Study ID Numbers
- NCI-2012-01450
- U01CA099168 (U.S. NIH Grant/Contract)
- 04-021
- NCI-6447
- MSKCC-04021
- CDR0000365463
- N01CM17105 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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