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

Phase 2
18 Years
Not Enrolling
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

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Trial Information

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


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.


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.

Inclusion Criteria:

- Histologically or cytologically confirmed gastric or gastroesophageal junction (GEJ)

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression, evaluated using RECIST

Outcome Description:

Kaplan-Meier estimates will be used.

Outcome Time Frame:

Up to 1 year

Safety Issue:


Principal Investigator

Manisha Shah

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021