Clinical trial NCT00277082: Aerosolized Liposomal Camptothecin in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung
Official title: Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) in Patients With Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corpus Uteri
Lung Cancer
Keywords: Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC)
Aerosolized Liposomal 9-Nitro 20
Camptothecin (L9NC)
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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 urine concentrations.

1.3. To determine the tumor concentration of 9NC administered by inhalation

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. Urine will be collected for 24 hours, and refrigerated. Upon completion of the collection, urine will be mixed, and a 20 ml aliquot frozen and preserved for further analysis.

A catheter will be placed in a peripheral vein, and in a peripheral artery, and appropriately heparinized.

Venous and arterial blood samples (7 ml per samples) will be drawn in heparinized green tops prior to DLPC-9NC administration, and at the following time points: 2, 5, 8, 12, and 24 hours. An additional 2 samples may be drawn at the PI discretion. (Total blood drawn: 84 ml + 14 ml)

During the GCRG hospitalization, a bronchoalveolar lavage (BAL) will be done according to standard practice once per patients. Patients will be divided in cohort of 6 (3 females and 3 males). Each cohort will undergo the BAL at a specific time point: within 30 minutes of the end of DLPC-9NC treatment, at 3 hours, 8 hours, and 24 hours.

In responding patients that may become surgical candidate for a curative resection, one DLPC-9NC treatment will be administered prior to surgery (within 5 hours). Surgery will proceed as per standard of care and patients will sign a regular surgical consent for surgical procedure. Along with the tumor removal, one sample of venous blood and of arterial blood will be drawn for comparison (total volume: 14 ml). Once the tumor specimen is removed, a piece will be kept in liquid nitrogen, along with a piece of normal lung tissue, for further analysis. Patients will need to sign the attached consent form to authorize the collection of specimens.

Eligibility criteria: For Endometrial:

Inclusion Criteria:

* 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 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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Claire Verschraegen, MD
role: PRINCIPAL_INVESTIGATOR
References: