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

Non Small Cell Lung Cancer Clinical Trial

— PRIDE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196234
• Other study ID #: AMC 2009-0677
• Status: Completed
• Phase: Phase 2
• First received: August 9, 2010
• Last updated: January 28, 2013
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Paclitaxel/Carboplatin/Gefitinib
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15
• Paclitaxel/Carboplatin
paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		average 6 months	No
Secondary	progression free survival		average 2 years	No
Secondary	overall survival		average 2 years	No