NCT00084604

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

3.5 years

First QC Date

June 10, 2004

Last Update Submit

June 3, 2013

Conditions

Adenocarcinoma of the Gastroesophageal JunctionDiffuse Adenocarcinoma of the StomachIntestinal Adenocarcinoma of the StomachMixed Adenocarcinoma of the StomachRecurrent Gastric CancerStage IIIA Gastric CancerStage IIIB Gastric CancerStage IIIC Gastric CancerStage IV Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to progression, evaluated using RECIST

    Kaplan-Meier estimates will be used.

    Up to 1 year

Secondary Outcomes (5)

  • 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

  • Incidence of toxicity, evaluated using CTCAE version 3.0

    Up to 1 year

Study Arms (1)

Treatment (bevacizumab, cisplatin, irinotecan)

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.

Drug: irinotecan hydrochlorideBiological: bevacizumabDrug: cisplatinProcedure: computed tomographyOther: laboratory biomarker analysis

Interventions

irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Treatment (bevacizumab, cisplatin, irinotecan)
bevacizumabBIOLOGICAL

Given IV

Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Treatment (bevacizumab, cisplatin, irinotecan)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Treatment (bevacizumab, cisplatin, irinotecan)
computed tomographyPROCEDURE

Correlative studies

Also known as: tomography, computed
Treatment (bevacizumab, cisplatin, irinotecan)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bevacizumab, cisplatin, irinotecan)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +54 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

IrinotecanBevacizumabCisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Manisha Shah

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

April 1, 2004

Primary Completion

October 1, 2007

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)