Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases (NCT03093909) | Clinical Trial Compass
RecruitingPhase 1
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
United States44 participantsStarted 2017-11-22
Plain-language summary
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.
The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.
The safety and side effects of this drug will also be studied.
This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work.
Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.
Who can participate
Age range12 Years â 50 Years
SexALL
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Inclusion criteria
â. Patients with diagnosis of solid tumor with lung metastases and patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
â. Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs).
â. Adequate organ function as defined by: peripheral absolute neutrophil count (ANC) \>/= 1,000/mm3, platelet count \>/= 100,000/mm3 (transfusion independent defined as not receiving platelet transfusions within a 7 day period prior to enrollment), hemoglobin \>/= 8.0g/dl (may receive RBC transfusions), renal-creatinine \</= 2 x ULN; hepatic- bilirubin and AST \</= 5x ULN; pulmonary: FVC \>/=50% predicted, Oxyhemoglobin saturation at rest \>/=95% (off supplemental oxygen).
â. Patient age \>/= 12 years and \</= 50 years.
â. Performance Status: ECOG \</= 2 for patients \>/= 16 years old or Lansky play \>/= 60% for patients \</=15 years old.
â. Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to NCI CTCAE Grade \</= 1 or to the baseline laboratory values as defined in the inclusion criteria.
â. No radiotherapy within 2 weeks.
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What they're measuring
1
Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB)
Timeframe: 4 weeks
2
Toxicities of Aerosol Gemcitabine (GCB)
Timeframe: Reviewed with each 4 week cycle, up to 24 weeks for six dose levels
. Subjects who received GCB systemically previously are eligible for participation.
Exclusion criteria
â. Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from asthma as a child and outgrew it.
â. Pregnant or breastfeeding women will not be entered into this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in females who are post-menarchal and of child bearing potential (e.g. female that has not been amenorrheic for at least 12 consecutive months or surgically sterilized). Males or females of reproductive potential will not participate unless they have agreed to use effective contraception for the entire period in which they are receiving protocol therapy and for at least one month after treatment ends. Effective contraception is defined as intrauterine device (IUD), hormonal (birth control pill, injections, implants, patch), tubal ligation and partner's vasectomy. Abstinence is an acceptable method of birth control.
â. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
â. Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \>/= 2 (CTCAE v4.0).
â. Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy.
â. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Grade \</= 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (eg, hearing loss).