Status:
COMPLETED
Aerosolized Liposomal Camptothecin in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung
Lead Sponsor:
University of New Mexico
Conditions:
Corpus Uteri
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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...
Detailed Description
TREATMENT PLAN (25-28) Patients will be admitted to the GCRC for 25 hours. Admission will be prior to the daily DLPC-9NC administration Upon admission, patients will be asked to empty their bladder....
Eligibility Criteria
Inclusion
- For Endometrial:
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00277082
Start Date
August 1 2003
End Date
June 1 2005
Last Update
January 7 2010
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131