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

NCT00277082 | Completed DMC

• 1 other identifier: 1302C
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Corpus Uteri; Lung Cancer

Keywords

Metastatic or Recurrent Cancer of the Endometrium or the Lung (NSCLC); Aerosolized Liposomal 9-Nitro 20; Camptothecin (L9NC)

Interventions

9-NC in aerosol reservoir DRUG

Samples will be minced or centrifuged and L9NC extracted by chromatography. L9NC will be measured by HPLC or mass spectrometry

Also known as: Liposomal-Nitro-20 (S)-Camptothecin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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:
• 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.
• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, lung tissue, lung cancer tissue.

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis; Endometrial Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Claire Verschraegen, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 12, 2006
• First Posted: January 13, 2006
• Study Start: August 1, 2003
• Study Completion: June 1, 2005
• Last Updated: January 7, 2010

Record last verified: 2008-04

Locations

US (1)