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

Phase 2

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Paclitaxel/Carboplatin/Gefitinib; Drug: Paclitaxel/Carboplatin

• Registration Number: NCT01196234
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-09-07
• Study First Posted: 2010-09-08
• Primary Completion: 2012-02
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel/Carboplatin/Gefitinib	Paclitaxel/Carboplatin/Gefitinib	Paclitaxel/Carboplatin/Gefitinib
Paclitaxel/Carboplatin	Paclitaxel/Carboplatin	Paclitaxel/Carboplatin

Primary Outcome Measures

Name	Time	Method
Response Rate	average 6 months

Secondary Outcome Measures

Name	Time	Method
progression free survival	average 2 years
overall survival	average 2 years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of