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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborator: AstraZeneca
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Gefitinib; Paclitaxel

Criteria

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.