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Anti-metabolites

Inhaled Gemcitabine for Cancer with Lung Spread

Q: Has Gemcitabine been cleared by the Food and Drug Administration?

Gemcitabine's safety has only been assessed in limited trials, so it was assigned a score of 1.

Q: Does the patient eligibility for this research include those over 45 years of age?

To participate in this medical trial, patients must be between 12 and 50 years of age. There are 398 studies focusing on minors and 3464 for elderly individuals respectively.

Q: What medical condition is Gemcitabine usually prescribed for?

Gemcitabine is an efficacious treatment for <a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> (<a href="https://www.withpower.com/clinical-trials/sclc">sclc</a>), head and neck carcinoma, as well as locally advanced pancreatic adenocarcinoma.

Q: What is the scale of participants for this research study?

Affirmative, the details found on clinicaltrials.gov indicate that this medical trial is undergoing recruitment of participants. This venture was published to the website in November 2017 and last modified on October 26th 2022; it seeks 44 individuals at a single venue.

Q: Do I qualify to partake in the experiment?

This clinical trial is seeking 44 participants aged between 12 and 50 who presently have neoplasm metastasis. Eligibility criteria also stipulate that no radiotherapy has been received within the last fortnight, subjects must not have previously had GCB systemically, be ECOG &#x3C;/= 2 if over 16 years old or Lansky play >/= 60% for those under 15 years of age, have a diagnosis of solid tumor with lung metastases, and meet the patient age requirement (>/=12 to &#x3C;/=50).

Q: Are there any prior research studies that have used Gemcitabine?

At present, 446 active trials are assessing the efficacy of Gemcitabine with 134 in Phase 3. Most investigations into this drug are occurring within Woolloongabba, Queensland; though there remain 24567 centres conducting clinical research across the globe.

Q: Is the research team currently looking for participants to join their experiment?

According to the official clinicaltrial.gov listing, this study is still recruiting participants. It was initially announced on November 22nd 2017 and has been modified most recently on October 26th 2022.

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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Toxicities of Aerosol Gemcitabine (GCB)

Secondary outcome measures

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

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

James B. and Lois R. Archer Charitable FoundationUNKNOWN

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,302 Total Patients Enrolled

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,526 Total Patients Enrolled

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03093909 — Phase 1

Bladder Cancer Research Study Groups: Aerosol Gemcitabine (GCB)

Bladder Cancer Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT03093909 — Phase 1

Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03093909 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Gemcitabine been cleared by the Food and Drug Administration?

"Gemcitabine's safety has only been assessed in limited trials, so it was assigned a score of 1."

Answered by AI

Does the patient eligibility for this research include those over 45 years of age?

"To participate in this medical trial, patients must be between 12 and 50 years of age. There are 398 studies focusing on minors and 3464 for elderly individuals respectively."

Answered by AI

What medical condition is Gemcitabine usually prescribed for?

"Gemcitabine is an efficacious treatment for small cell lung cancer (sclc), head and neck carcinoma, as well as locally advanced pancreatic adenocarcinoma."

Answered by AI

What is the scale of participants for this research study?

"Affirmative, the details found on clinicaltrials.gov indicate that this medical trial is undergoing recruitment of participants. This venture was published to the website in November 2017 and last modified on October 26th 2022; it seeks 44 individuals at a single venue."

Answered by AI

Do I qualify to partake in the experiment?

"This clinical trial is seeking 44 participants aged between 12 and 50 who presently have neoplasm metastasis. Eligibility criteria also stipulate that no radiotherapy has been received within the last fortnight, subjects must not have previously had GCB systemically, be ECOG </= 2 if over 16 years old or Lansky play >/= 60% for those under 15 years of age, have a diagnosis of solid tumor with lung metastases, and meet the patient age requirement (>/=12 to </=50)."

Answered by AI

Are there any prior research studies that have used Gemcitabine?

"At present, 446 active trials are assessing the efficacy of Gemcitabine with 134 in Phase 3. Most investigations into this drug are occurring within Woolloongabba, Queensland; though there remain 24567 centres conducting clinical research across the globe."

Answered by AI

Is the research team currently looking for participants to join their experiment?

"According to the official clinicaltrial.gov listing, this study is still recruiting participants. It was initially announced on November 22nd 2017 and has been modified most recently on October 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03093909.

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