Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pegylated Liposomal Doxorubicin and Carboplatin as First Line Treatment for Patients With Advanced Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01051362
Recruitment Status : Unknown
Verified January 2006 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : January 18, 2010
Last Update Posted : January 18, 2010
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University

Tracking Information
First Submitted Date  ICMJE January 15, 2010
First Posted Date  ICMJE January 18, 2010
Last Update Posted Date January 18, 2010
Study Start Date  ICMJE February 2006
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
To evaluate the overall response rate (complete and partial responses) in previously untreated advanced non-small-cell lung cancer (NSCLC) treated with Pegylated liposomal doxorubicin and Carboplatin [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2010)
To evaluate the progression-free survival (PFS) and overall survival (OS) in previously untreated advanced NSCLC treated with Pegylated liposomal doxorubicin and Carboplatin [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pegylated Liposomal Doxorubicin and Carboplatin as First Line Treatment for Patients With Advanced Non-small Cell Lung Cancer
Official Title  ICMJE Phase II Study of Pegylated Liposomal Doxorubicin and Carboplatin as First Line Treatment for Patients With Advanced Non-small Cell Lung Cancer
Brief Summary This Phase II study is to explore the efficacy and toxicity of Pegylated liposomal doxorubicin and Carboplatin in patients with previously untreated non-small cell lung cancer (NSCLC) not amenable to radiotherapy or surgical treatment. The planned enrollment for this trial is 48 patients (including a 10% rate for inevaluable patients).
Detailed Description Pegylated liposomal doxorubicin (PLD) is the first antineoplastic drug derived from the new technology of liposome formulation to be introduced in clinical practice. The low myocardium uptake of this formulation accounts for its reduced cardiac toxicity, confirmed both in preclinical models and in humans. Preclinical data have shown activity in NSCLC xenografts. This Phase II study is to explore the efficacy and toxicity of Pegylated liposomal doxorubicin and Carboplatin in patients with previously untreated non-small cell lung cancer (NSCLC) not amenable to radiotherapy or surgical treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Drug: PLD and Carboplatin
Pegylated liposomal doxorubicin (PLD) 30 mg/m2, followed by Carboplatin AUC (area under the curve) 5, every 21 days for 4 cycles or until progression.
Study Arms  ICMJE No Intervention: PLD and Carboplatin
Pegylated liposomal doxorubicin (PLD) 30 mg/m2, followed by Carboplatin AUC (area under the curve) 5, every 21 days for 4 cycles or until progression.
Intervention: Drug: PLD and Carboplatin
Publications * Numico G, Castiglione F, Granetto C, Garrone O, Mariani G, Costanzo GD, Ciura PL, Gasco M, Ostellino O, Porcile G, Merlano M. Single-agent pegylated liposomal doxorubicin (Caelix) in chemotherapy pretreated non-small cell lung cancer patients: a pilot trial. Lung Cancer. 2002 Jan;35(1):59-64.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 15, 2010)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed non-small-cell bronchogenic carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable. Mixed tumors with small-cell anaplastic elements are not eligible.
  • Patients who have newly diagnosed unresectable stage III or IV disease are eligible. Patients with stage III disease should be ineligible for combined modality therapy (i.e., pleural effusions, pericardial effusions, etc.).
  • Patients must not have received any prior antineoplastic chemotherapy for metastatic lung cancer prior to study entry.
  • Patients who have had previous radiotherapy as definitive therapy for locally advanced non-small-cell are eligible as long as the recurrence is outside the original radiation port. Radiation therapy must have been completed greater than 4 weeks prior to registration.
  • Male or female patients >=18 years of age.
  • Life expectancy of at least 3 months.
  • ECOG performance status of <=2.
  • Measurable disease by RECIST criteria.
  • Laboratory values as follows: ANC >=1500/mm3 (7 days prior to treatment); Hemoglobin >=8 g/dL;Platelets >=100,000 mm3 (7 days prior to treatment); Bilirubin <=1 x ULN for institution; AST/SGOT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases and ALT/SGPT <=2.5 x ULN or <=5.0 x ULN in patients with liver metastases; Creatinine <=2.0 mg/dL or Calculated (measured) GFR >=40 mL/min; PT/INR and PTT <=1.5 x ULN
  • Peripheral neuropathy <= grade 1.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment.
  • Patient must be accessible for treatment and follow-up.
  • All patients must be able to understand the nature of the study and give written informed consent prior to study entry.

Exclusion Criteria:

  • A history of cardiac disease as defined by malignant hypertension, unstable angina, congestive heart failure of > grade 2 per New York Heart Association (NYHA) criteria, myocardial infarction within the previous 6 months, or symptomatic cardiac arrhythmias.
  • Metastatic brain or meningeal tumors.
  • Uncontrolled intercurrent illness.
  • Chemotherapy, investigational drug therapy, or major surgery ≤ 4 weeks prior to starting study drug, or patients who have not recovered from side effects of previous therapy.
  • Patient is <=5 years free of another primary malignancy, except if the other primary malignancy is not currently clinically significant or requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
  • Concomitant use of any anti-cancer therapy or radiation therapy.
  • Other concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01051362
Other Study ID Numbers  ICMJE FAHG20060216
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Department of Cardiothoracic Surgery, The First Affiliated Hospital of Guangzhou Medical College
Study Sponsor  ICMJE The First Affiliated Hospital of Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianxing He, MD, FACS Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
PRS Account The First Affiliated Hospital of Guangzhou Medical University
Verification Date January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP