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Retinoid
Bexarotene + Tretinoin and Chemotherapy for Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Raghu Nandan, M.D., Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Absence of hepatic dysfunction characterized by Bilirubin ≤ 3 times ULN (unless due to liver metastases)
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side effects of giving bexarotene and tretinoin with combination chemotherapy in treating patients with non-small cell lung cancer.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (Stage III or IV) who haven't had chemotherapy. They must have normal liver function, not be pregnant, and agree to use contraception. People can join if they've had certain prior treatments like erlotinib or radiation for brain metastases but must have a good performance status.Check my eligibility
What is being tested?
The study tests bexarotene and tretinoin combined with chemotherapy drugs cisplatin, carboplatin, docetaxel, and capecitabine. It aims to see if this combination slows tumor growth more effectively than standard treatments in patients with advanced lung cancer.See study design
What are the potential side effects?
Possible side effects include skin reactions from bexarotene exposure to light, increased blood lipids leading to pancreatitis risk, fatigue from chemotherapy agents, potential liver dysfunction symptoms, and general discomfort such as nausea or hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is functioning well, with bilirubin levels not more than 3 times the normal limit.
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I can take care of myself and perform daily activities.
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My lung cancer is confirmed to be non-small cell type.
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My condition is at stage IV.
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My cancer is at stage IIIB with fluid buildup due to cancer.
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I am receiving radiation therapy to ease symptoms.
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My liver tests are normal or only high due to cancer spread.
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I have not received chemotherapy for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate as measured by RECIST criteria
Time to progression
Secondary outcome measures
Patient-reported symptoms and side effects
Survival
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Who is running the clinical trial?
Raghu Nandan, M.D., IncLead Sponsor
1 Previous Clinical Trials
Raghu Nandan, MDStudy ChairRaghu Nandan, M.D., Inc
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use condoms during the study and for 1 month after if my partner could become pregnant.I can take care of myself and perform daily activities.My lung cancer is confirmed to be non-small cell type.My condition is at stage IV.Your ANC (a type of white blood cell) count is at least 1,500 per cubic millimeter.I cannot take Lipitor^® or levothyroxine due to health reasons.My cancer is at stage IIIB with fluid buildup due to cancer.I am willing and able to avoid sunlight and UV light while on bexarotene.I have previously used bexarotene.My liver is functioning well, with bilirubin levels not more than 3 times the normal limit.I have taken a drug like erlotinib for up to 3 months without my cancer responding.I have received treatments like immunotherapy or chemotherapy before.I haven't taken more than 15,000 IU/day of vitamin A in the last 2 weeks.I've had treatment other than brain radiation, and I still have a measurable tumor.I am receiving radiation therapy to ease symptoms.I have another cancer, but it's not skin cancer, early prostate cancer, or a localized tumor.You need to have a negative pregnancy test before starting the treatment.My liver tests are normal or only high due to cancer spread.I am currently taking gemfibrozil (Lopid).I have risk factors for pancreatitis such as high cholesterol, heavy drinking, uncontrolled diabetes, or gallbladder issues.Your platelet count is at least 100,000 per cubic millimeter.I have untreated hypothyroidism.You are allergic to bexarotene or any of its ingredients.I agree to avoid pregnancy or fathering a child by using two forms of birth control or abstaining from sex during the study and for 1 month after.I do not have any serious ongoing illnesses.I am not on any cancer treatments other than what this study requires.I am not taking medication that raises my triglyceride levels or harms my pancreas.I have not received chemotherapy for my condition.I have brain metastases but have completed radiation and they are not getting worse.
Research Study Groups:
This trial has the following groups: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment slots still open for this medical investigation?
"According to the information found on clinicaltrials.gov, this medical trial is no longer open for recruitment; it was initially posted on January 1st 2007 and last updated in September 2014. Despite being closed off from enrollment, there are still 2041 other trials looking for participants at present."
Answered by AI
Has this intervention been validated by the FDA?
"Our risk assessment team at Power placed a score of 2 on this treatment's safety profile as it is currently in Phase 2 testing, meaning there are data backing its security yet none that demonstrate efficacy."
Answered by AI
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