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Alkylating agents

Inhaled Chemotherapy + IV Chemotherapy for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Zivena

Eligibility Criteria Checklist

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

Must have

Creatinine <1.5 mg/dL or creatinine clearance > 60 mL/min/1.7 m2 BSA

Histologic or cytologic proof of locally advanced or metastatic unresectable NSCLC, Patients with the pneumonic form of BAC, or cavitary lesions > 3.5 cm or with cavitary lesions of any size with air/fluid levels are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test whether adding inhaled chemotherapy to a standard IV chemotherapy treatment plan increases efficacy while also measuring any additional toxicities.

Who is the study for?

Adults over 18 with advanced or metastatic NSCLC who haven't had chemo or biologic therapy for lung cancer. They must have good liver, kidney, and bone marrow function, no prior lung radiotherapy (except certain cases), acceptable pulmonary function tests, and not be pregnant or breastfeeding. Those with serious active infections, known drug hypersensitivity, unstable heart conditions, uncontrolled diabetes, other cancers treated within the last 5 years (with exceptions), or using investigational drugs can't join.Check my eligibility

What is being tested?

The trial is testing if inhaled Doxorubicin can be effectively combined with standard IV chemotherapy drugs Docetaxel and Cisplatin in treating NSCLC. It aims to assess any additional side effects from this combination and gather preliminary results on its effectiveness against lung cancer.See study design

What are the potential side effects?

Potential side effects may include typical reactions to chemotherapy such as nausea, fatigue, hair loss; specific concerns might involve lung-related issues due to inhalation like coughing or shortness of breath; plus risks associated with each individual drug like mouth sores from Doxorubicin or nerve damage from Docetaxel.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is normal, based on creatinine levels or clearance.

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My lung cancer is advanced but hasn't spread to my brain, and it can't be removed by surgery.

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I have not had chemotherapy or biologic therapy for lung cancer.

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My lung function tests show I have good breathing capacity and oxygen levels.

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I am fully active or can carry out light work.

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My lung condition can be measured or evaluated.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

ZivenaLead Sponsor

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00082472 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups:

Non-Small Cell Lung Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00082472 — Phase 1 & 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00082472 — Phase 1 & 2

Frequently Asked Questions

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

Are there any open spots for individuals to join this trial?

"According to clinicialtrials.gov, this medical study is no longer enrolling patients as the trial was last updated in April 2006. Nonetheless, there are still 670 other trials actively recruiting across the country."

Answered by AI

Does this trial accept participants aged 80 or younger?

"The enrollment criteria for this medical trial requires that participants are 18 or older but not yet 65 years old."

Answered by AI

Is it feasible for me to join this research project?

"This trial is seeking 30 individuals with non-small cell lung carcinoma (nsclc) over the age of 18. Eligibility criteria include: Never having received a chemotherapeutic or biologic therapy for lung cancer, being an adult aged >18 years, and exhibiting an Eastern Cooperative Oncology Group Performance Status score of 0 to 1."

Answered by AI

What is the geographical scope of this trial's operations?

"This medical trial is running in numerous locations, most prominently the Yale University Cancer Center located in New Haven Connecticut, Southern Nevada Cancer Research Foundation situated in Las Vegas, and Arthur G James Cancer Hospital & Richard Solove Research Institute at Ohio State University found in Columbus."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

2004. "Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00082472.

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