Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
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|ClinicalTrials.gov Identifier: NCT03093909|
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : November 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Bone and Articular Cartilage Malignant Neoplasms of Female Genital Organs Malignant Neoplasms of Independent (Primary) Multiple Sites Malignant Neoplasms of Lip Oral Cavity and Pharynx Malignant Neoplasm of Male Genital Organs Malignant Neoplasms of Mesothelial and Soft Tissue Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma Malignant Neoplasms of Thyroid and Other Endocrine Glands Malignant Neoplasms of Urinary Tract Melanoma and Other Malignant Neoplasms of Skin||Drug: Gemcitabine||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases|
|Actual Study Start Date :||November 22, 2017|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Experimental: Aerosol Gemcitabine (GCB)
Dose Escalation Cohort: Participants take Gemcitabine by mist 2 times each week for 4 weeks (28 days).
Expansion Cohort: Participants with OS lung metastases receive study drug at the maximum tolerated dose from Dose Escalation Cohort.
Participants may continue to receive the study drug for up to 12 cycles per decision of doctor.
Nebulized dose of aerosol GCB twice a week continuously (escalating treatment dose schema, starting at 0.75 mg/kg to 3.0 mg/kg). Participants receive a pre-determined volume of nebulized solution, according to the dose level and weight of the participant, with each aerosol GCB administration. One cycle is 4 weeks in duration.
- Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB) [ Time Frame: 4 weeks ]
MTD is defined as highest dose level with six patients with at most 1 dose limiting toxicity (DLT) occurring during cycle 1. Dose levels will continue to be increased until 1 participant experiences DLT. If only 1 of 3 participants experiences DLT, 3 additional patients will be entered.
Dose escalation conducted via accelerated titration method for first 2 dose levels followed by 3+3 method for remaining dose levels. Cohorts of 1 participant per dose level for first 2 dose levels. If at any time during cycle 1 there is an instance of pulmonary grade 2 toxicity or pulmonary function tests (PFT) decline>10% related to study drug, current dose level expanded to 3 participants & switched to 3+3 design. If neither of these nor any other DLT occur in dose levels 1-2, switch will be to the 3 + 3 design beginning with dose level 3. Three participants will be treated at dose level 3, if still no DLT, 3 more treated at dose level 4.
- Toxicities of Aerosol Gemcitabine (GCB) [ Time Frame: Reviewed with each 4 week cycle, up to 24 weeks for six dose levels ]
Dose limiting toxicities associated with the MTD of aerosol GCB using the NCI Common Terminology Criteria version 4 for Adverse Events (CTCAE) will be utilized for AE reporting. DLT defined as any of the following events that are at least (possibly, probably or definitely) attributable to aerosol GCB. The observation period for the purposes of dose-escalation will be the first cycle of therapy.
DLT Definition includes:
- Any episode of respiratory (bronchospasm, cough and/or dyspnea) grade 2 toxicity.
- or > 10% decrease in FEV1 that persists > 3 days after the drug is stopped or recurrent episode of respiratory (bronchospasm, cough and/or dyspnea) grade 2 toxicity.
- Any grade 3 or 4 non-hematological toxicity.
- Any grade 4 neutropenia or thrombocytopenia.
- Assessment of Serum Levels of Aerosol Gemcitabine (GCB) [ Time Frame: Day 1 of therapy ]Assessment of serum levels of Gemcitabine (GCB) for evidence of spillover into the circulation and correlate with presence or absence of toxicity.
- Response of Serum Levels of Aerosol Gemcitabine (GCB) [ Time Frame: Baseline, end of Cycles 2, 4, and 6, and then every 3 cycles up to 30 days after study dose stopped. Cycles are 28 days. ]Response evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093909
|Contact: Najat C. Daw-Bitar, MD||713-792-3280||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Principal Investigator:||Najat C. Daw-Bitar, MD||The University of Texas MD Anderson Cancer Center|