NCT01051362

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2006

Enrollment Period

5 years

First QC Date

January 15, 2010

Last Update Submit

January 15, 2010

Conditions

Non-small Cell Lung Cancer

Keywords

Advanced Non-small Cell Lung CancerPegylated liposomal doxorubicinCarboplatinChemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • To evaluate the progression-free survival (PFS) and overall survival (OS) in previously untreated advanced NSCLC treated with Pegylated liposomal doxorubicin and Carboplatin

    6 months

Study Arms (1)

PLD and Carboplatin

NO INTERVENTION

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.

Drug: PLD and Carboplatin

Interventions

PLD and CarboplatinDRUG

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.

PLD and Carboplatin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

  • 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. doi: 10.1016/s0169-5002(01)00269-0.

    PMID: 11750714BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

1-dodecylpyridoxalCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Jianxing He, MD, FACS

    Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenlong Shao, MD

CONTACT

+86-20-83337750myfriends2003@126.com

Daoyuan Wang, MD

CONTACT

+86-20-83337750ghealth2008@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

February 1, 2006

Primary Completion

February 1, 2011

Study Completion

November 1, 2011

Last Updated

January 18, 2010

Record last verified: 2006-01

Locations

CN(1)