Clinical Trial: Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

Brief Summary: 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.

Detailed Summary:

Study Drug Administration:

If found to be eligible to take part in this study, participants will be assigned to a dose level of gemcitabine based on when participants join this study. Up to 6 dose levels of gemcitabine will be tested. Up to 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects are seen. This will continue until the highest tolerable dose of gemcitabine is found.

Each study cycle is 28 days. Participants will visit the clinic before the start of every cycle to receive their doses of the study drug for the next cycle. Participants will be provided with a machine called a nebulizer to make the gemcitabine mist. To take the study drug, participant will breathe the drug mist through the mouthpiece of the nebulizer.

Participant will take gemcitabine by mist 2 times each week for 4 weeks (28 days). The study staff will tell participant which days to take the study drug. If the doctor thinks it is in participant's best interest, participant may continue to receive the study drug for up to 12 cycles.

Length of Study:

Participant may continue taking the study drug for up to 12 cycles. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions. If participant has developed a tumor outside of the lungs either before or while participant is on study, and the doctor thinks it is in participant's best interest, participant may have a local control procedure (such as radiation or surgery), that may
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome:

  • 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.

  • Dose Limiting Toxicities (DLT) of aerosol 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.

    Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: March 21, 2017
    Date Started: June 2017
    Date Completion: June 2021
    Last Updated: April 19, 2017
    Last Verified: April 2017