Study of Weekly Paclitaxel, Carboplatin and Irinotecan to Treat Lung Cancer - Full Text View

Sponsored by:	Sidney Kimmel Comprehensive Cancer Center
Information provided by:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00465907

Purpose

Evaluate the efficacy and toxicity of the weekly combination chemotherapy of Paclitaxel, Carboplatin and Irinotecan in Stage IIIb and IV NSCLC with maligant pleural effusion

Condition	Intervention	Phase
Lung Cancer	Drug: Paclitaxel, Carboplatin, Irinotecan	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Carboplatin Irinotecan Irinotecan hydrochloride Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Weekly Paclitaxel, Carboplatin and Irinotecan in Patients With Advanced Non-Small Cell Lung Cancer Nad Malignant Plerual Effusion

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

To evaluate the efficacy and toxicity of the weekly combination chemotherapy of paclitaxel, carboplatin and irinotecan in Stage IIIB and IV NSCLC patients with malignant pleural effusion [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the pharmacokinetics and pharmacodynamics of paclitaxel and irinotecan in the blood and pleural effusion. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To compare the gene expression pattern of non-small cell lung cancer from cigarette-smoking, passive smoking and no tobacco exposure patients before and after chemotherapy. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	May 2003
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Paclitaxel-60mg/m2 weekly for 3 weeks Carboplatin - AUC 1.5, weekly for 3 weeks Irinotecan - 60mg/m2, weekly for 3 weeks

Detailed Description:

Lung cancer is the leading cancer death in many countries of the world including Singapore. Non-small cell lung cancer (NSCLC) consists of 80-85% of lung cancers, and is a major health problem. The main etiology of lung cancer is well recognized and established to be cigarette smoking which accounts for up to 80% of the cases in the western countries. Due to success of anti-smoking campaig, we anticipate to see less smoking related lung cancer and more non-smoking related lung cancer which is rising rapidly. For eg, currently in Singapore, smoking only accounts for 50-60% of all lung cancers, this is particularly true in female patients, as smoking occured in 30-40% of female lung cancer patients only.

It is unclear if there is any significant difference in the fundamental biology between smoking and non-smoking related lung cancers, particularly in areas of natural course of disease, genetic changes of tumor cells, clinical presentation, response to treatment or survival. These are potential aspects for further investigation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histological or cytological diagnosis of non-small cell lung cancer.
Malignant pleural effusion proven by cytological examination.
Patient must have stage IIIB or IV disease with malignant pleural effusion.
We plan to recruit 16 patients who have smoked cigarettes of at least 20 pack per year, 16 patients who do not smoke but have been exposed to second hand smoking by living with a person who has smoked 20 pack per year cigarette in the same household and 16 patients who are non-smokers (never smoked) and no second hand smoking exposure in the same household. The accrual will be stopped once the number of patients is reached in each group.
ECOG PS 0, 1 or 2.
Measurable disease (in addition to malignant pleural effusion).
No prior chemotherapy for metastatic or recurrent disease. Patient may have surgery or radiation or combined chemoradiation, or neoadjuvant chemotherapy at primary diagnosis. This kind of chemotherapy will not be counted as patient has had prior chemotherapy for metastatic or recurrent NSCLC.
WBC > 3500/uL and ANC > 2,000/uL, platelet > 100,000/uL AST/ALT < 3 X UNL, bilirubin < 1.5 mg/dL ( or < 35 uM), creatinine < 1.5 mg/dL (or < 125uM for men and 90uM for women).
Age > 18
No history of congestive heart failure, myocardial infarction or life-threatening arrthymia (such as ventricular tachycardia, supraventricular tachycardia, brachycardia < 40/min or atrial fibrillation or flutter with ventricular rate > 150/min) within 6 months of entry.
Signed informed consent
Negative mammogram and ovaries examination by CT scans and no history of breast cancer or ovarian cancer in female patients.
Negative pregnancy test in female menstruating patient within one week of starting chemotherapy and use of effective contraceptive methods during study.
Patients with brain metastasis will be eligible provided their neurological abnormality is stable or improved after whole brain radiation, stereostatic radiosurgery or gamma knife treatment and/or dexamethasone for 3 weeks and patients fulfil all other eligibility criteria.

Exclusion Criteria:

ECOG performance status 3 or worse.
Any prior chemotherapy regimen for metastatic or recurrent diseases.
No measurable disease, even after drainage of pleural effusion.
ANC < 1,999/uL or Bilirubin > 1.5 mg/dL (or > 35uM)
Plt < 100,000/uL or
ALT/AST > 3 x UNL
Creatinine > 1.5mg/dL (or > 125uM)

Patient has history of congestive heart failure, myocardial infarction or life-threatening arrthymia (such as ventricular tachycardia, supraventricular tachycardia, atrial fibrillation/flutter with ventricular rate > 150/min or bradycardia < 40/min) within 6 months before entry.

Prior history of breast cancer or ovarian cancer in female patients or any cancer except cured cervical carcinoma in-situ or skin cancer.

Fasting blood sugar > 200 mg/dL (> 14uM) except in patients on dexamethasone for brain metastases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465907

Locations

Singapore
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

Investigators

Principal Investigator:

Alex Chang, MD

Johns Hopkins SIngapore International Medical Center

More Information

Responsible Party:	Johns Hopkins Singapore International Medical Center ( Dr Alex Chang / Medical Director )
Study ID Numbers:	JS 0312
Study First Received:	April 23, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00465907
Health Authority:	Singapore: Domain Specific Review Boards; Singapore: Health Sciences Authority; United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

lung cancer with malignant pleural effusion

Study placed in the following topic categories:

Thoracic Neoplasms
Pleural Effusion
Non-small cell lung cancer
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms

Lung Diseases
Irinotecan
Pleural Effusion, Malignant
Carboplatin
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Mitosis Modulators
Tubulin Modulators
Enzyme Inhibitors
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009