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Phase II Study of Weekly Paclitaxel, Carboplatin and Irinotecan in Patients With Advanced Non-Small Cell Lung Cancer Nad Malignant Plerual Effusion


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase II Study of Weekly Paclitaxel, Carboplatin and Irinotecan in Patients With Advanced Non-Small Cell Lung Cancer Nad Malignant Plerual Effusion


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Alex Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins SIngapore International Medical Center

Authority:

Singapore: Domain Specific Review Boards

Study ID:

JS 0312

NCT ID:

NCT00465907

Start Date:

May 2003

Completion Date:

December 2009

Related Keywords:

  • Lung Cancer
  • lung cancer with malignant pleural effusion
  • Lung Neoplasms

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