- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01024712
Paclitaxel, Carboplatin, and Gefitinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
Primary
- To determine the efficacy, in terms of overall response, and safety of paclitaxel and carboplatin in combination with intermittent gefitinib in patients with advanced nonsquamous non-small cell lung cancer.
Secondary
- Determine the disease-control rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive paclitaxel IV on day 1, carboplatin IV on day 2, and oral gefitinib once daily on days 8-17. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with complete response or partial response may continue maintenance therapy comprising oral gefitinib once daily in the absence of disease progression or unacceptable toxicity.
Patients complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline, during study treatment, and after completion of study treatment for quality-of-life study.
After completion of study treatment, patients are followed every 2 months for 2 years and then every 4 months thereafter.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Beijing, China, 100021
- Recruiting
- Cancer Institute Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Yuankai Shi, MD, PhD
- Phone Number: 86-10-137-0125-1865
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall-response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free survival
|
Overall survival
|
Quality of life
|
Safety
|
Disease-control rate
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yuankai Shi, MD, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Protein Kinase Inhibitors
- Carboplatin
- Paclitaxel
- Gefitinib
Other Study ID Numbers
- CIH-CAMS-CHL-020
- CDR0000643743 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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