Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations. Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.

Detailed Description
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A randomized phase II trial that compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with NSCLC without EGFR mutations. While previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.

Official Title
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Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel/Carboplatin/Gefitinib
* Drug: Paclitaxel/Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 years of age Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion. At least 1 measurable lesion as defined by RECIST1.0. All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment. ECOG PS 0-2 At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy. Patients must have adequate hematologic, renal and liver function as defined by Hb > 9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST (SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit). Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures. Written and voluntary informed consent understood, signed and dated. Exclusion Criteria: Patients with tumor harboring EGFR mutation. Prior systemic therapy for NSCLC Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study. Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms. Major surgery within 3 weeks prior to study enrollment. Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin. Severe medical illness or active infection that would impair the ability to receive gefitinib. Pregnancy or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel/Carboplatin/Gefitinib<br>Paclitaxel/Carboplatin/Gefitinib | Drug: Paclitaxel/Carboplatin/Gefitinib<br>* paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15<br>|
| Active Comparator: Paclitaxel/Carboplatin<br>Paclitaxel/Carboplatin | Drug: Paclitaxel/Carboplatin<br>* paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | average 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | average 2 years | 
| overall survival |  | average 2 years |