Clinical trial NCT00465907: Study of Weekly Paclitaxel, Carboplatin and Irinotecan to Treat Lung Cancer
Official title: Phase II Study of Weekly Paclitaxel, Carboplatin and Irinotecan in Patients With Advanced Non-Small Cell Lung Cancer Nad Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: lung cancer with malignant pleural effusion
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 campaign, 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 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 arrhythmia (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 arrhythmia (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.

Primary outcomes:
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
timeFrame: 3 years
Secondary outcomes:
measure: To determine the pharmacokinetics and pharmacodynamics of paclitaxel and irinotecan in the blood and pleural effusion.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Johns Hopkins Singapore International Medical Center
Study officials:
affiliation: Johns Hopkins Singapore
name: Alex Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: