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Anti-metabolites

Inhaled Gemcitabine for Cancer with Lung Spread

Phase 1

Recruiting

Led By Najat C. Daw-Bitar, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient age >/= 12 years and </= 50 years

Subjects who received GCB systemically previously are eligible for participation

Must not have

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

Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is studying a higher dose of a cancer drug given by inhalation to see if it is safe and effective in treating patients with solid tumors that have spread to the lungs.

Who is the study for?

This trial is for patients aged 12-50 with solid tumors that have spread to the lungs, where no curative or life-prolonging treatments are suitable. Participants must be willing to follow the study's procedures and have good organ function. They can't join if they're using bronchodilators/corticosteroids, have uncontrolled illnesses, are pregnant/breastfeeding, or suffer from certain symptoms like fever or cough.

What is being tested?

The study aims to determine the highest dose of gemcitabine that can be safely inhaled by patients with lung metastases from other cancers. All participants will receive this treatment at MD Anderson Cancer Center, and up to 44 individuals will take part.

What are the potential side effects?

Potential side effects include typical reactions associated with chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Inhalation may cause respiratory issues like coughing or shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 50 years old.

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I have previously received GCB treatment.

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My blood, kidney, liver, and lung functions meet the required levels for the trial.

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I am 16 or older and can care for myself, or I am 15 or younger and can do most activities.

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My cancer has spread to my lungs and there's no cure or treatment to significantly extend my life with good quality.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I am not currently receiving any cancer treatments like chemotherapy.

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I have moderate to severe fever, cough, shortness of breath, wheezing, or fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB)

Toxicities of Aerosol Gemcitabine (GCB)

Secondary study objectives

Assessment of Serum Levels of Aerosol Gemcitabine (GCB)

Response of Serum Levels of Aerosol Gemcitabine (GCB)

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aerosol Gemcitabine (GCB)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

FDA approved

0 / 8Eligibility criteria met