Cisplatin and Irinotecan Chemotherapy, Followed by ZD 1839 (Iressa) in Patients With Esophageal or Gastric Carcinomas

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00215995
First received: September 19, 2005
Last updated: January 12, 2012
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: Cisplatin
Drug: Irinotecan
Drug: ZD 1839
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Cisplatin and Irinotecan Induction Chemotherapy, Followed by ZD 1839 (IRESSA) in Adult Patients With Surgically Unresectable and/or Metastatic Esophageal or Gastric Carcinomas

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Participants With Desired Response [ Time Frame: 48 Months ] [ Designated as safety issue: No ]
    Response rate


Secondary Outcome Measures:
  • Duration of Participants' Desired Response [ Time Frame: 48 Months ] [ Designated as safety issue: No ]
    Response duration in months

  • Participants' Time to Disease Progression [ Time Frame: 48 Months ] [ Designated as safety issue: No ]
    Time to progression in months

  • Number of Participants With Overall Survival [ Time Frame: 48 Months ] [ Designated as safety issue: No ]
    Overall survival from first participant On Treatment to last participant Off Study


Enrollment: 21
Study Start Date: July 2003
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin, Irinotecan and ZD1839
As outlined in Detailed Description.
Drug: Cisplatin
As outlined in Detailed Description
Other Names:
  • Platinol
  • Platinol-AQ
Drug: Irinotecan
As outlined in Detailed Description
Other Name: Camptosar
Drug: ZD 1839
As outlined in Detailed Description
Other Name: Iressa

Detailed Description:

This is an open-label, non-randomized, multicenter Phase II study designed to evaluate tumor response rates in patients with surgically unresectable and/or metastatic esophageal, esophagogastric, and gastric adenocarcinoma or squamous carcinoma. Study schema is as follows. Patients will receive Irinotecan and Cisplatin on days 1 and 8 every 21 days for a maximum of 6 cycles of therapy. This is then followed by ZD 1839 (Iressa), which is an oral pill taken once daily. During the Iressa phase, patients will be evaluated every 6 weeks. This includes labs, CT scans and physical examination. The exploratory objective of the study is to examine the correlation between epidermal growth factor receptor (EGFR) expression and radiographic response to treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Aged 18 years or older
  • Provision of written informed consent
  • For patients with locally advanced disease, subjects must be evaluated by a radiation oncologist prior to study entry, and judged that radiation therapy is not indicated in the subjects therapy.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215995

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Puerto Rico
Ponce School of Medicine
Ponce, Puerto Rico, 00732
University of Puetro Rico Cancer Center
San Juan, Puerto Rico, 00936-5067
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
AstraZeneca
Investigators
Principal Investigator: Chris Garrett, MD H. Lee Moffitt Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00215995     History of Changes
Other Study ID Numbers: MCC-13426, USFIRB#101525
Study First Received: September 19, 2005
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
esophageal cancer
esophagogastric cancer
gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Irinotecan
Gefitinib
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014