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Gefitinib and Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer

This study has been withdrawn prior to enrollment.
(Study never moved forward with accrual.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00268255
First received: December 20, 2005
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with gefitinib and to see how well they work in treating patients with inoperable stage I or stage II non-small cell lung cancer.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: gefitinib
Procedure: adjuvant therapy
Procedure: enzyme inhibitor therapy
Procedure: neoadjuvant therapy
Procedure: protein tyrosine kinase inhibitor therapy
Procedure: radiation therapy
Procedure: radiosensitization
Phase 1
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: Phase I/II Study of Induction Gefitinib and Concurrent Radiotherapy in Patients With Previously Untreated, Medically Inoperable Stage I or II Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Enrollment: 0
Detailed Description:

OBJECTIVES:

Primary

  • Determine the toxicity profile and maximum tolerated dose of radiotherapy when given in combination with gefitinib in patients with previously untreated, medically inoperable stage I or II non-small cell lung cancer. (Phase I)
  • Determine the efficacy of gefitinib when given for 6 weeks prior to and concurrent with radiotherapy, in terms of objective response rate (partial and complete response), in these patients.

Secondary

  • Determine the 3-month tumor response (complete and partial response) in patients treated with this regimen.
  • Determine the 6-week response rate in patients treated with this regimen.
  • Determine the local disease control rate (complete and partial response, stable disease) in patients treated with this regimen.
  • Determine the local progression-free survival and disease-specific survival (cancer vs co-morbid disease) of patients treated with this regimen.
  • Determine the pattern of failure (e.g., local, regional, or distant metastasis) in patients treated with this regimen.
  • Determine the acute and late radiation toxic effects to organs at risk in patients treated with this regimen.
  • Determine the safety profile of gefitinib in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study of radiotherapy.

  • Patients receive oral gefitinib once daily for 13 weeks. Patients also undergo radiotherapy 5 days a week for 7 weeks beginning at week 7. Patients continue to receive gefitinib alone after completion of radiotherapy in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience acute dose-limiting toxicity.

  • Phase II: Patients receive oral gefitinib as in phase I and radiotherapy at the MTD determined in phase I. After the completion of radiotherapy, patients continue to receive gefitinib in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Any non-small cell histology allowed
  • T1-3, N0* disease
  • No metastatic disease
  • Refused or ineligible for surgery
  • Measurable disease, defined as lesion diameter ≤ 5 cm NOTE: *No evidence of N1 or N2 disease by positron emission tomography (PET) scan or any histological means (mediastinoscopy, thoracotomy, transbronchial, tracheal aspirations, or transesophageal aspiration by endoscopic ultrasound guidance

PATIENT CHARACTERISTICS:

Performance status

  • Any performance status

Life expectancy

  • At least 1 year

Hematopoietic

  • No restrictions

Hepatic

  • No restrictions

Renal

  • Creatinine ≤ CTC grade 2

Pulmonary

  • No clinically active interstitial lung disease
  • Chronic, stable, asymptomatic radiographic changes allowed

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No known severe hypersensitivity to gefitinib or any of the excipients of this product
  • No other malignancy within the past 5 years except basal cell cancer or carcinoma in situ of the cervix
  • No active or uncontrolled infection
  • No uncontrolled systemic disease
  • No psychiatric illness or other severe medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • No prior chemotherapy

Radiotherapy

  • No prior radiotherapy to the chest or mediastinum
  • No concurrent elective nodal irradiation

Surgery

  • Recovered from prior surgery
  • No concurrent ophthalmic surgery

Other

  • Recovered from all other prior anticancer therapy (alopecia allowed)
  • More than 30 days since prior nonapproved or investigational agents
  • No concurrent CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Barbiturates
  • Rifampin
  • Phenobarbital
  • Hypericum perforatum (St. John's wort)
  • No concurrent systemic retinoids
  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: NCT00268255

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
AstraZeneca
Investigators
Study Chair: Andrew T. Turrisi, MD Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00268255     History of Changes
Other Study ID Numbers: CDR0000447160, WSU-D-2820, WSU-HIC-100304M1F, ZENECA-1839US/0258
Study First Received: December 20, 2005
Last Updated: April 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
squamous cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Enzyme Inhibitors
Gefitinib
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014