Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

irinotecan hydrochloride

+ bevacizumab

+ cisplatin

DrugBiologicalProcedureOther
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, 2004

Actual 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 enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialStomach DiseasesStomach 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.

Study Objectives

Primary Objectives

Secondary Objectives

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 Center

New York, United StatesSee the location
CompletedOne Study Center