Aerosolized Liposomal Camptothecin in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung

Completed

Conditions studied: Corpus Uteri, Lung Cancer

In brief

To determine the concentration of 9-nitrocamptothecin (9NC) in the alveolar fluid over time. 1.2. To determine the arterial concentration of 9NC administered by inhalation in comparison to venous and urine concentrations. 1.3. To determine the tumor concentration of 9NC administered by inhalation

Key facts

Study ID

NCT00277082

Run by

University of New Mexico

People needed

24

Starts

2003-08-01

Expected to finish

2005-06-01

Last updated by the study team

2010-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients, 18 years of age or older, with metastatic and/or recurrent endometrial cancer or with mixed mesenchymal malignant tumors whose epithelial component is recurring, who have failed standard chemotherapy or hormonal regimens for their disease or who refuse recommended standard chemotherapy are eligible.
• Patients must have a life expectancy of at least 12 weeks.
• Patients much 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.

You may not qualify if…

• 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.
• For Lung:
• Inclusion Criteria:
• All patients, 18 years of age or older, with stage 3b, 4, or recurrent, nonresectable, non-small-cell lung carcinoma 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 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.

Where it is running

• University of New Mexico — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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