Paclitaxel, Carboplatin, and Gefitinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

NCT01024712 | Unknown Phase 2

• 2 other identifiers: CIH-CAMS-CHL-020CDR0000643743
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and carboplatin together with gefitinib may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving paclitaxel and carboplatin together with gefitinib and to see how well it works in treating patients with Stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall-response rate

Secondary Outcomes (5)

• Disease-control rate

• Safety

• Quality of life

• Progression-free survival

• Overall survival

Interventions

carboplatin DRUG

gefitinib DRUG

paclitaxel DRUG

quality-of-life assessment PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * No squamous cell carcinoma * Untreated Stage IIIB or IV disease not suitable for surgery or radiotherapy OR patients with postoperative recurrence who had never been treated by chemotherapy * No history of smoking or light smoking (\< 10 packs a year and smoking abatement ≥ 15 years) * At least 1 measurable tumor mass (length \> 1.5 cm and width \> 1.0 cm) * No symptomatic brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute neutrophil count ≥ 2 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * ALT and AST ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤1.5 times ULN * Serum creatinine normal * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignant tumors within the past year except for basal cell or squamous cell carcinoma of the skin, or in situ malignant cancer that has been completely resected * No history of allergic reaction to any component of the drugs in this study PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 1 month since prior investigational drugs or medical devices * No prior chemotherapy or radiotherapy for this tumor * No concurrent liposomal paclitaxel * No other concurrent antitumor therapy (e.g., radiotherapy or surgical treatment) * No other concurrent anticancer chemotherapy drugs or anticancer Chinese herbs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Carboplatin; Gefitinib; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Yuankai Shi, MD, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: May 1, 2009
• Last Updated: August 12, 2013

Record last verified: 2009-12

Locations

CN (1)