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Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

Phase 2
18 Years
Not Enrolling
Lung Diseases, Cancer

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Trial Information

Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

This is a single-arm, non-randomized Phase II trial of DLPC-9NC administered by aerosol 5
consecutive days per week for 8 weeks every 10 weeks.

Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day)
per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks.

Patients that have a resectable lung cancer will only receive one course of treatment and
will be operated on about two weeks after completing the 8-week course.

Inclusion Criteria:

- All patients, 18 years of age or older, with resectable lung cancer (any stage) or
stage 3b, 4, or recurrent, nonresectable, non-small-cell lung carcinoma, who have
failed standard chemotherapy or radiotherapy for their disease or who refuse standard
therapy are eligible.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must have a Zubrod performance status of 0-2.

- Patients must sign an informed consent.

- Patients should have adequate bone marrow function defined by an absolute peripheral
granulocyte count of >1,500 or cells/mm3 and platelet count >100,000/mm3 and absence
of a regular red blood cell transfusion requirement.

- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and
SGOT or SGPT < two times the upper limit of normal, and adequate renal function as
defined by a serum creatinine < 1.5 x upper limit of normal.

- Patients must not have a known symptomatic respiratory disease other than cancer, and
must have a pulmonary function test equal to >50% FEV1, >50% FEV1/FVC, >50% TLC, and
>50% DLCO of predicted values.

Exclusion Criteria:

- Patients with symptomatic brain metastases are excluded from this study.

- Pregnant women or nursing mothers are not eligible for this trial. Patients of child
bearing potential must use adequate contraception.

- Patients may receive no other concurrent chemotherapy or radiation therapy during
this trial.

- Patients with severe medical problems such as uncontrolled diabetes mellitus or
cardiovascular disease or active infections are not eligible for this trial.

- Any criteria that is borderline and may lead to ineligibility will be reviewed by the
PI, who may override the eligibility criteria, after receiving sponsor agreement, if
entry into the study is deemed to potentially benefit the patient.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization in patients with non-small-cell lung cancer (any stage).

Outcome Time Frame:

disease progression or unacceptable toxicities

Safety Issue:


Principal Investigator

Claire F Verschraegen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Food and Drug Administration

Study ID:




Start Date:

April 2003

Completion Date:

December 2007

Related Keywords:

  • Lung Diseases
  • Cancer
  • Phase II
  • Aerosol Delivery
  • 9-Nitrocamptothecin
  • Lung Diseases



University of New Mexico Albuquerque, New Mexico  87131