Neoadjuvant IRESSA As Single Agent PreopTherapy for NSCLC With Molecular Correlates

NCT00104728 | Terminated Results

• 2 other identifiers: MCC-13922IRUSIRES0256
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so it can be removed. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients who are undergoing surgery for stage I, stage II, or stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IA non-small cell lung cancer; stage IB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.

  3 years

Secondary Outcomes (1)

• Frequency of Toxicity Related to Study Treatment

  3 years

Study Arms (1)

Neoadjuvant ZD1839 Preoperative Therapy

EXPERIMENTAL

The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food. At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.

Drug: ZD1839

Interventions

ZD1839 DRUG

Also known as: IRESSA®, gefitinib

Neoadjuvant ZD1839 Preoperative Therapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed resectable non-small cell lung cancer (NSCLC), meeting 1 of the following clinical staging criteria: * Stage IA or IB (T1-2, N0) * Stage II (T1-2, N1 with negative mediastinoscopy or T3, N0) * Stage IIIA (T3, N1 with negative mediastinoscopy) * Level 10 hilar nodes may be positive provided mediastinoscopy is negative * The following are not allowed (as evidenced by clinical staging criteria \[CT scan, positron-emission tomography (PET) scan, or mediastinoscopy): * Positive N2 lymph nodes (ipsilateral/subcarinal mediastinal lymph nodes) * Positive N3 lymph nodes (contralateral mediastinal/hilar and supraclavicular/scalene lymph nodes) * T4 primary tumor (malignant pleural effusion or mediastinal invasion) * Symptomatic tumors (T3, N0-1) involving the superior sulcus (i.e., Pancoast tumors) * Measurable disease by contrast-enhanced CT scan * No metastatic disease (except peribronchial or hilar lymph node involvement \[N1\]) by fludeoxyglucose F 18 PET scan * No malignant pleural effusion by preoperative evaluation * Pleural effusions visible only on CT scan that are not large enough for safe thoracentesis are allowed * No exudative effusions (even if cytologically negative), as evidenced by any of the following: * Ratio of pleural fluid protein to serum protein \> 0.5 * Ratio of pleural fluid lactic dehydrogenase (LDH) to serum LDH ≥ 0.6 * Pleural fluid LDH \> 200 IU/L * No superior vena cava syndrome * No spinal cord compression PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy * Not specified Hematopoietic * WBC ≥ 4,000/mm\^3 * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST or ALT ≤ 2 times ULN * Alkaline phosphatase ≤ 2 times ULN Renal * Creatinine \< 1.5 times ULN Cardiovascular * No uncontrolled ventricular arrhythmia * No myocardial infarction within the past 3 months Pulmonary * Pre-resection FEV\_1 \> 2.0 L OR * Predicted post-resection FEV\_1 \> 1.0 L * No clinically active interstitial lung disease * Chronic stable asymptomatic radiographic changes allowed * No post-obstructive pneumonia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing to provide tumor biopsy pre- and post-gefitinib administration AND undergo PET scan * No known severe hypersensitivity to study drug or any of its excipients * No uncontrolled major seizure disorder * No unstable or uncontrolled diabetes mellitus * No serious infection requiring IV antibiotics * No grade 3 neuropathy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No other unstable or serious medical condition that would preclude study treatment or surgery * No psychiatric disorder that would preclude giving informed consent * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow up * No other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior or concurrent systemic chemotherapy for NSCLC Endocrine therapy * Not specified Radiotherapy * No prior or concurrent radiotherapy for NSCLC Surgery * Recovered from prior oncologic or other major surgery * At least 5 years since prior resection of lung disease * No prior surgery for NSCLC * No concurrent ophthalmic surgery Other * More than 30 days since prior non-approved or investigational drugs * No other concurrent therapy for NSCLC * No other concurrent investigational therapy * No concurrent use of any of the following medications: * Phenytoin * Carbamazepine * Barbiturates (e.g., phenobarbital) * Rifampin * Hypericum perforatum (St. John's wort)

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator
• AstraZeneca: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Pilot study. At the time of interim analysis, the second early stopping rule was invoked for lack of activity (not enough responses to continue). Study closed to accrual 5/9/08.

Results Point of Contact

• Title: Dr. Eric Haura
• Organization: H. Lee Moffitt Cancer Center and Research Institute

eric.haura@moffitt.org

813-745-6826

Study Officials

• Eric B. Haura, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: October 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: March 1, 2009
• Last Updated: October 31, 2012
• Results First Posted: October 31, 2012

Record last verified: 2012-09

Locations

US (1)