Completed

A Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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What is being tested

irinotecan hydrochloride

+ bevacizumab
+ cisplatin
Drug
Biological
Procedure
Other
Who is being recruted

Adenocarcinoma
+9

+ Carcinoma
+ Digestive System Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleA Multicenter, Open-Label, Phase II Study of Irinotecan, Cisplatin, and Bevacizumab in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma 
NCT00084604
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
47 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Adenocarcinoma
Carcinoma
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Stomach Diseases
Stomach Neoplasms
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 * 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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
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.

Given IV

Given IV

Given IV

Correlative studies

Correlative studies
Study Objectives
Primary Objectives

Kaplan-Meier estimates will be used.
Secondary Objectives

95% exact binomial confidence intervals will be used to describe the distribution.

95% exact binomial confidence intervals will be used to describe the distribution.

Kaplan-Meier estimates will be used.


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Memorial Sloan-Kettering Cancer CenterNew York, United StatesSee the location

CompletedOne Study Center
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