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Alkylating agents
Reduced-Dose Chemotherapy for Lung Cancer
Phase 2
Recruiting
Led By Julia Judd, DO
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
ECOG performance status of 0-3
Must not have
Leptomeningeal disease
Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Summary
This trial will measure how well chemotherapy works in lung cancer patients with other illnesses.
Who is the study for?
This trial is for adults over 18 with stage IV lung cancer (small cell or non-small cell) or inoperable stage III. They may have had previous treatments and can have stable, treated brain metastases. Participants must be able to perform daily activities (ECOG 0-3), not be pregnant, agree to use contraception, and plan to receive one of the listed chemotherapy drugs.
What is being tested?
The study tests lower doses of common chemotherapy drugs like Carboplatin and Paclitaxel in patients with other health issues. It's an open-label phase II trial, meaning everyone gets treatment and researchers know what's given. The goal is to see how well patients tolerate these reduced doses while monitoring effectiveness.
What are the potential side effects?
Possible side effects include nausea, fatigue, hair loss, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations, allergic reactions during drug infusion, kidney issues from certain drugs like Cisplatin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I can care for myself but may not be able to do heavy physical work.
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My treatment plan includes chemotherapy drugs like platinum or taxane.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread to the lining of my brain and spinal cord.
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I need special feeding methods due to stomach or bowel problems.
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I do not have any uncontrolled illnesses that could interfere with the study.
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I am only on targeted therapy or immunotherapy, not chemotherapy.
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I have severe difficulty in performing daily activities and have liver or kidney problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Frequency of adverse events
Overall survival (OS)
Progression free survival (PFS)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Single agent chemotherapy with or without a VEGFiExperimental Treatment10 Interventions
Group II: Platinum doublet with or without a VEGFiExperimental Treatment10 Interventions
Group III: Platinum doublet plus immunotherapy (IO)Experimental Treatment10 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Pemetrexed
2014
Completed Phase 3
~5550
Paclitaxel
2011
Completed Phase 4
~5810
Nab paclitaxel
2014
Completed Phase 2
~580
Irinotecan
2017
Completed Phase 3
~2580
Lurbinectedin
2022
Completed Phase 2
~90
Gemcitabine
2017
Completed Phase 3
~1920
Carboplatin
2014
Completed Phase 3
~6120
Etoposide
2010
Completed Phase 3
~2960
Topotecan
2017
Completed Phase 3
~2460
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
233 Previous Clinical Trials
38,631 Total Patients Enrolled
Julia Judd, DOPrincipal InvestigatorFox Chase Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I am a man who will use birth control during and 6 months after the study.I have another cancer, but it won't affect this trial's treatment.I have brain metastases but don't need steroids, had no recent brain radiation, and if on seizure meds, my condition is stable.I have HIV under control with medication, no recent severe infections, and my immune system is relatively strong.My cancer has spread to the lining of my brain and spinal cord.I still have side effects from cancer treatment, but only things like nerve pain, hair loss, or hormone issues.My lung cancer is at stage IV or stage III without options for a cure.I need special feeding methods due to stomach or bowel problems.I am on treatments for low calcium and my levels are now normal.Your corrected serum calcium level is higher than 12 mg/dl.I have had treatments for lung cancer before, regardless of how many.I can care for myself but may not be able to do heavy physical work.I have not had major surgery in the last 28 days and do not plan to during the trial.I do not have any uncontrolled illnesses that could interfere with the study.I don't need frequent procedures to remove excess fluid from my body.You are currently taking experimental drugs for cancer.I am only on targeted therapy or immunotherapy, not chemotherapy.I agree to use birth control during and for 6 months after the study.My treatment plan includes chemotherapy drugs like platinum or taxane.You need to have a measurable disease based on specific criteria.I have severe difficulty in performing daily activities and have liver or kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Platinum doublet plus immunotherapy (IO)
- Group 2: Platinum doublet with or without a VEGFi
- Group 3: Single agent chemotherapy with or without a VEGFi
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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