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Study of Weekly Paclitaxel, Carboplatin and Irinotecan to Treat Lung Cancer

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ClinicalTrials.gov Identifier: NCT00465907
Recruitment Status : Unknown
Verified December 2008 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2007
Last Update Posted : December 17, 2008
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Drug: Paclitaxel, Carboplatin, Irinotecan Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Paclitaxel, Carboplatin and Irinotecan in Patients With Advanced Non-Small Cell Lung Cancer Nad Malignant Plerual Effusion
Study Start Date : May 2003
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources


Intervention Details:
    Drug: Paclitaxel, Carboplatin, Irinotecan
    Paclitaxel-60mg/m2 weekly for 3 weeks Carboplatin - AUC 1.5, weekly for 3 weeks Irinotecan - 60mg/m2, weekly for 3 weeks


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine the pharmacokinetics and pharmacodynamics of paclitaxel and irinotecan in the blood and pleural effusion. [ Time Frame: 3 years ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465907


Locations
Singapore
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Alex Chang, MD Johns Hopkins SIngapore International Medical Center

Responsible Party: Dr Alex Chang / Medical Director, Johns Hopkins Singapore International Medical Center
ClinicalTrials.gov Identifier: NCT00465907     History of Changes
Other Study ID Numbers: JS 0312
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: December 17, 2008
Last Verified: December 2008

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
lung cancer with malignant pleural effusion

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Irinotecan
Camptothecin
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors