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

NCT00465907 | Terminated Phase 2

• 2 other identifiers: JS 0312NA_00037282
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

lung cancer with malignant pleural effusion

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (2)

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

  3 years

• 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.

  3 years

Study Arms (1)

Paclitaxel, Carboplatin and Irinotecan

EXPERIMENTAL

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

Drug: Paclitaxel, Carboplatin and Irinotecan

Interventions

Paclitaxel, Carboplatin and Irinotecan DRUG

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

Paclitaxel, Carboplatin and Irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Singapore International Medical Center

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Paclitaxel; Carboplatin; Irinotecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Alex Chang, MD

  Johns Hopkins Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: May 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: February 1, 2014
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

SG (1)