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

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

carboplatin

gefitinib

paclitaxel

quality-of-life assessment

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cancer Institute Hospital, Chinese Academy of Medical SciencesRecruiting

Outcomes

Primary Outcome Measures

Overall-response rate

Secondary Outcome Measures

Disease-control rate

Safety

Quality of life

Progression-free survival

Overall survival

Full Information

NCT ID

NCT01024712

First Posted

December 2, 2009

Last Updated

August 9, 2013

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01024712

Brief Title

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

Official Title

Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Unknown status

Study Start Date

May 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Type

Drug

Intervention Name(s)

gefitinib

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Primary Outcome Measure Information:

Title

Overall-response rate

Secondary Outcome Measure Information:

Title

Disease-control rate

Title

Safety

Title

Quality of life

Title

Progression-free survival

Title

Overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuankai Shi, MD, PhD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Institute Hospital, Chinese Academy of Medical Sciences

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuankai Shi, MD, PhD

Phone

86-10-137-0125-1865

12. IPD Sharing Statement

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

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