NCT00215995

Brief Summary

This study is for patients with esophageal, esophagogastric, or gastric cancer that has spread to other parts of the body. The purpose of this study is to test the safety and effectiveness of a new experimental drug called ZD 1839 following initial therapy with two other chemotherapy drugs, called Irinotecan (CPT-11) and Cisplatin.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2003

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

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

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 13, 2012

Status Verified

May 1, 2007

Enrollment Period

3.8 years

First QC Date

September 19, 2005

Last Update Submit

January 12, 2012

Conditions

Esophageal CancerGastric Cancer

Keywords

esophageal canceresophagogastric cancergastric cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Desired Response

    Response rate

    48 Months

Secondary Outcomes (3)

  • Duration of Participants' Desired Response

    48 Months

  • Participants' Time to Disease Progression

    48 Months

  • Number of Participants With Overall Survival

    48 Months

Study Arms (1)

Cisplatin, Irinotecan and ZD1839

EXPERIMENTAL

As outlined in Detailed Description.

Drug: CisplatinDrug: IrinotecanDrug: ZD 1839

Interventions

CisplatinDRUG

As outlined in Detailed Description

Also known as: Platinol, Platinol-AQ
Cisplatin, Irinotecan and ZD1839
IrinotecanDRUG

As outlined in Detailed Description

Also known as: Camptosar
Cisplatin, Irinotecan and ZD1839
ZD 1839DRUG

As outlined in Detailed Description

Also known as: Iressa
Cisplatin, Irinotecan and ZD1839

Eligibility Criteria

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

You may qualify if:

  • Histologic confirmation of esophageal carcinoma (squamous or adenocarcinoma) or gastric adenocarcinoma.
  • Surgically unresectable disease and/or metastatic disease.
  • No prior chemotherapy therapy.
  • Life expectancy \> 12 weeks.
  • Patients must have the ability to take and retain oral medications.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky Performance Status \[KPS\] ≥50%).
  • Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and computerized tomographic scan performed within 28 days prior to registration.
  • Organ system function assessed within 7 days prior to registration and within the following parameters:
  • Absolute neutrophil count ≥1500/mL;
  • Platelet count ≥100,000/mL;
  • Hemoglobin level ≥10.0 gm/dL;
  • Serum creatinine ≤1.5 x IULN (Institutional Upper Limits of Normal); OR Measured creatinine clearance ≥60 mL/min;
  • AST (SGOT) or ALT (SGPT) ≤ 2.5 x IULN (unless the liver is involved by tumor, in which case it must be ≤5.0 x IULN);
  • Total bilirubin ≤1.5 x IULN.
  • Understanding of the subject of the potential and unknown teratogenic risk, as well as their willingness to practice birth control. Should a pregnancy occur while a subject, either father or mother, is receiving study medication, the subject should inform the doctor immediately.
  • +3 more criteria

You may not qualify if:

  • Prior treatment with EGFR-inhibiting agents, chemotherapy, or radiotherapy for esophagogastric carcinomas.
  • Patients must not be receiving any other investigational agents. Use of erythropoietin is allowable. Secondary prophylaxis with granulocyte colony stimulating factor (G-CSF) (Filgrastim) is allowable. The use of granulocyte-macrophage colony stimulating factor (GM-CSF) (Sargramostim) is not allowed on this protocol.
  • Uncontrolled brain metastases.
  • Patients must not have uncontrolled intercurrent illness at the time of registration including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients must not have current New York Heart Association Class III or IV heart disease.
  • Known human immunodeficiency virus (HIV) infection.
  • Pregnant or breast-feeding women.
  • Patients who have had prior malignancies, except non-melanoma skin cancer (basal or squamous cell carcinoma) are not eligible for this study; unless greater than 5 years has passed since the event.
  • Known severe hypersensitivity to ZD 1839 or any of the excipients of this product.
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's Wort.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
  • Incomplete healing from previous oncologic or other major surgery.
  • Serum creatinine level greater than Common Toxicity Criteria (CTC) grade 2.
  • Any evidence of clinically active interstitial lung disease. Subjects with chronic stable radiographic changes who are asymptomatic need not be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Ponce School of Medicine

Ponce, 00732, Puerto Rico

Location

University of Puetro Rico Cancer Center

San Juan, 00936-5067, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsStomach Neoplasms

Interventions

CisplatinIrinotecanGefitinib

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCamptothecinAlkaloidsHeterocyclic CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chris Garrett, MD

    H. Lee Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

July 1, 2003

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

January 13, 2012

Record last verified: 2007-05

Locations

US(1)PR(2)