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

Phase 2
18 Years
85 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

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

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.

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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Jianxing He, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


China: Food and Drug Administration

Study ID:




Start Date:

February 2006

Completion Date:

November 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Advanced Non-small Cell Lung Cancer
  • Pegylated liposomal doxorubicin
  • Carboplatin
  • Chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms