Status:
COMPLETED
Paclitaxel/Carboplatin (PC) Followed by Gefitinib Versus PC in Advanced Non-small Cell Lung Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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)...
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 cy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT01196234
Start Date
December 1 2009
End Date
December 1 2012
Last Update
January 29 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, South Korea, 138-736