Gefitinib and Celecoxib in Treating Patients With Refractory Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00068653
First received: September 10, 2003
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of cancer by stopping blood flow to the tumor. Combining gefitinib with celecoxib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gefitinib with celecoxib in treating patients who have non-small cell lung cancer that is refractory to platinum-based chemotherapy (such as cisplatin or carboplatin).


Condition Intervention Phase
Lung Cancer
Drug: Celecoxib
Drug: ZD1839
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 II Study of the Combination of ZD1839 (Iressa) and Celecoxib in Patients With Platinum Refractory Non-Small Cell Lung Cance

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate [ Time Frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation ] [ Designated as safety issue: No ]
    CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation ] [ Designated as safety issue: No ]
  • Toxicity of this drug combination [ Time Frame: Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: June 2003
Study Completion Date: May 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib & ZD1839

Celecoxib: 400mg orally two times a day, taken with meals.

ZD1839: 250 mg po every day, taken with or without food.

Drug: Celecoxib
Celecoxib 400mg orally two times a day, taken with meals.
Other Name: Celebrex
Drug: ZD1839
ZD1839 250 mg po every day, taken with or without food.
Other Names:
  • Iressa
  • Gefitinib

Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with platinum-refractory non-small cell lung cancer treated with gefitinib and celecoxib.

Secondary

  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive oral gefitinib once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 6 weeks.

PROJECTED ACCRUAL: A total of 18-27 patients will be accrued for this study within 22 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Progression of disease during platinum-based (cisplatin or carboplatin) chemotherapy or within 3 months of completing chemotherapy

    • Treatment with other agents since prior platinum-based chemotherapy allowed
  • Measurable disease

    • Target lesions within a prior radiation field must have documented evidence of progression at least 8 weeks after the completion of radiotherapy
  • No active brain or leptomeningeal metastases

    • Treated brain metastases allowed at least 4 weeks after the completion of appropriate therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 8 g/dL

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN (if alkaline phosphatase is no greater than ULN)
  • Alkaline phosphatase no greater than 5 times ULN (if AST and ALT are greater than ULN)
  • No history of chronic hepatitis

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No active thromboembolic event within the past 4 weeks
  • No uncontrolled congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction and/or stroke within the past 6 months

Pulmonary

  • No evidence of clinically active interstitial lung disease

Gastrointestinal

  • No history of gastrointestinal bleeding within the past 6 months
  • No history of peptic ulcer disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must weigh at least 110 pounds (50 kg)
  • HIV negative
  • No allergy to sulfonamides
  • No allergy to any NSAID, including celecoxib
  • No known severe hypersensitivity to gefitinib or any of its excipients
  • No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No history of dementia, active psychiatric disorder, or any other condition that would preclude study compliance
  • No other concurrent serious medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior epidermal growth factor receptor inhibitor
  • No concurrent biologic therapy

Chemotherapy

  • See Disease Characteristics
  • More than 2 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Recovered from prior radiotherapy

Surgery

  • Recovered from prior surgery

Other

  • Recovered from prior therapy
  • More than 2 weeks since prior investigational therapy
  • More than 1 week since prior fluconazole
  • More than 30 days since prior participation in another investigational agent clinical trial
  • More than 30 days since prior chronic nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib or rofecoxib
  • No prior gefitinib
  • No prior cyclooxygenase-2 (COX-2) inhibitor or another clinical trial for NSCLC
  • No other concurrent NSAIDs

    • Concurrent aspirin allowed (not to exceed 325 mg/day)
  • No other concurrent COX-2 inhibitors
  • No concurrent lithium
  • No concurrent fluconazole
  • No concurrent use of any of the following:

    • Phenytoin
    • Carbamazepine
    • Barbiturates
    • Rifampin
    • Phenobarbital
    • Hypericum perforatum
  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: NCT00068653

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00068653     History of Changes
Other Study ID Numbers: CDR0000327805, P30CA022453, WSU-C-2563, ZENECA-1839US/0252
Study First Received: September 10, 2003
Last Updated: April 25, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Celecoxib
Gefitinib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Antineoplastic Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014