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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00465907
First received: April 23, 2007
Last updated: December 16, 2008
Last verified: December 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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:
    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
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
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: 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

No publications provided

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
Study First Received: April 23, 2007
Last Updated: December 16, 2008
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

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Irinotecan
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014