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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01024712
First received: December 2, 2009
Last updated: August 9, 2013
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: gefitinib
Drug: paclitaxel
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall-response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-control rate [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: May 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024712

Locations
China
Cancer Institute Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Yuankai Shi, MD, PhD    86-10-137-0125-1865      
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Yuankai Shi, MD, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01024712     History of Changes
Other Study ID Numbers: CIH-CAMS-CHL-020, CDR0000643743
Study First Received: December 2, 2009
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014