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

NCT00068653 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000327805P30CA022453WSU-C-2563ZENECA-1839US/0252
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  CT scan chest/abdomen; Assessments of complete response (CR) or partial response (PR)require confirmation 4 weeks or later.

  Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation

Secondary Outcomes (3)

• Progression-free survival (PFS)

  Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation

• Overall survival

  Every 2 cycles; after the 1st 4 cycles, every month by clinical exam & every 3 months radiological evaluation

• Toxicity of this drug combination

  Every 2 weeks; Every month after 4 cycles if the patient has not developed > Grade 2 toxicity

Study Arms (1)

Celecoxib & ZD1839

EXPERIMENTAL

Celecoxib: 400mg orally two times a day, taken with meals. ZD1839: 250 mg po every day, taken with or without food.

Drug: Celecoxib; Drug: ZD1839

Interventions

Celecoxib DRUG

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

Also known as: Celebrex

Celecoxib & ZD1839

ZD1839 DRUG

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

Also known as: Iressa, Gefitinib

Celecoxib & ZD1839

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib; Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shirish M. Gadgeel, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

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 10, 2003
• First Posted: September 11, 2003
• Study Start: June 1, 2003
• Primary Completion: October 1, 2007
• Study Completion: May 1, 2008
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)