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

Primary Purpose

Lung Cancer

Status

Terminated

Phase

Phase 2

Locations

Singapore

Study Type

Interventional

Intervention

Paclitaxel, Carboplatin and Irinotecan

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring lung cancer with malignant pleural effusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Johns Hopkins Singapore International Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel, Carboplatin and Irinotecan

Arm Description

Study of Weekly Paclitaxel, Carboplatin and Irinotecan in patients with Non-Small Cell Lung Carcinoma

Outcomes

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

Secondary Outcome Measures

To determine the pharmacokinetics and pharmacodynamics of paclitaxel and irinotecan in the blood and pleural effusion.

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.

Full Information

NCT ID

NCT00465907

First Posted

April 23, 2007

Last Updated

February 7, 2019

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1. Study Identification

Unique Protocol Identification Number

NCT00465907

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

Low accrual

Study Start Date

May 2003 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

lung cancer with malignant pleural effusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel, Carboplatin and Irinotecan

Arm Type

Experimental

Arm Description

Study of Weekly Paclitaxel, Carboplatin and Irinotecan in patients with Non-Small Cell Lung Carcinoma

Intervention Type

Drug

Intervention Name(s)

Paclitaxel, Carboplatin and Irinotecan

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To determine the pharmacokinetics and pharmacodynamics of paclitaxel and irinotecan in the blood and pleural effusion.

Time Frame

3 years

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alex Chang, MD

Organizational Affiliation

Johns Hopkins Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Singapore International Medical Center

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

12. IPD Sharing Statement

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

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