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

NCT01196234 | Completed Phase 2

• 1 other identifier: AMC 2009-0677
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate

  average 6 months

Secondary Outcomes (2)

• progression free survival

  average 2 years

• overall survival

  average 2 years

Study Arms (2)

Paclitaxel/Carboplatin/Gefitinib

EXPERIMENTAL

Paclitaxel/Carboplatin/Gefitinib

Drug: Paclitaxel/Carboplatin/Gefitinib

Paclitaxel/Carboplatin

ACTIVE COMPARATOR

Paclitaxel/Carboplatin

Drug: Paclitaxel/Carboplatin

Interventions

Paclitaxel/Carboplatin/Gefitinib DRUG

paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15

Paclitaxel/Carboplatin/Gefitinib

Paclitaxel/Carboplatin DRUG

paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)

Paclitaxel/Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Choi YJ, Lee DH, Choi CM, Lee JS, Lee SJ, Ahn JH, Kim SW. Randomized phase II study of paclitaxel/carboplatin intercalated with gefitinib compared to paclitaxel/carboplatin alone for chemotherapy-naive non-small cell lung cancer in a clinically selected population excluding patients with non-smoking adenocarcinoma or mutated EGFR. BMC Cancer. 2015 Oct 22;15:763. doi: 10.1186/s12885-015-1714-y.

  PMID: 26493267 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; CP protocol

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Sang-We Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2010
• First Posted: September 8, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

KR (1)