Lung CancerPhase 2NCT00514293
Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing bexarotene, capecitabine and carboplatin in people with Lung Cancer, run by Raghu Nandan, M.D., Inc at 1 site in United States.
Trial summary
RATIONALE: Bexarotene and tretinoin may cause tumor cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as cisplatin, carboplatin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- bexarotene, capecitabine and carboplatin
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status 0-2
- Absence of hepatic dysfunction that is characterized by the following:
- AST/ALT > 3 times upper limit of normal (ULN) (unless due to liver metastases)
- Bilirubin > 3 times ULN (unless due to liver metastases)
- ANC ≥ 1,500/mm^3
- Platelets ≥ 100,000/mm^3
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- Negative pregnancy test prior to the initiation of treatment
- Female and male patients of childbearing potential must agree to sexual abstinence for at least 4 weeks prior to study OR practice 2 reliable forms of effective contraception simultaneously (strongly recommended that one of the two forms of contraception be non-hormonal) at least 4 weeks prior to, during the entire study treatment, and for at least 1 month after treatment is discontinued
- Male patients with female sexual partners who are pregnant, possibly pregnant, or who could become pregnant during the study must agree to use condoms during sexual intercourse during the entire study treatment and for at least 1 month after the last dose of bexarotene
- Must be willing and able to give informed consent, comply with study instructions, and commit to all study visits
- Tyrosine kinase inhibitor therapy such as erlotinib hydrochloride is allowed for up to 3 months prior to initiation of this regimen provided the disease is unresponsive to such treatment
- Concurrent radiation therapy administered for symptom relief
- Also see Disease Characteristics
Who cannot join
- Pregnancy, intent to become pregnant, or breast-feeding
- Significant concurrent or intercurrent illness
- Risk factor for pancreatitis (e.g., uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease)
- Untreated hypothyroidism
- Active second malignancy with the exception of carcinoma in situ, early-stage prostate cancer, and squamous or basal cell carcinoma of skin
- Unwillingness or inability to minimize exposure to sunlight and artificial ultraviolet light while receiving bexarotene
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- Known contraindication (according to product labeling) to Lipitor^® (or another selected lipid lowering agent) or levothyroxine
- Known hypersensitivity to bexarotene or other component of bexarotene
- PRIOR CONCURRENT THERAPY:
- Prior therapy, except radiation to the brain for palliation, as long as a measurable lesion is still present
- Prior use of bexarotene
- Prior systemic anticancer therapy (e.g., immunotherapy, chemotherapy, or biologic modifier therapy)
- Medication known to increase triglyceride levels or associated with pancreatic toxicity
- Systemic vitamin A in doses exceeding 15,000 IU/day within 14 days prior to initiating study therapy
- Concurrent gemfibrozil (Lopid^®)
- Concurrent anticancer therapy of any kind other than that mandated by the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
R. Nandan M.D. Incorporated
Lakewood, California, 90712
Raghu Nandan, MD, 562-272-7630, traghu9@hotmail.com
About this study
Official title: Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer
RATIONALE: Bexarotene and tretinoin may cause tumor cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as cisplatin, carboplatin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bexarotene and tretinoin together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bexarotene together with tretinoin and combination chemotherapy works in treating patients with stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of bexarotene at a dose of 375 mg daily for 4 days with tretinoin also for the same 3 days with chemotherapy in patients with advanced non-small cell lung cancer.
- Evaluate the safety and tolerability of this drug combination.
OUTLINE: Patients will receive oral bexarotene 375 mg once daily and oral tretinoin 50 mg twice daily on days 1-3. Patients also receive combination chemotherapy comprising cisplatin or carboplatin with docetaxel and capecitabine orally or intravenously on days 1-3. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed every 4 weeks.
- Conditions
- Lung Cancer
- Being tested
- bexarotene, capecitabine, carboplatin, cisplatin, docetaxel
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bexaroteneDrug
capecitabineDrug
carboplatinDrug
cisplatinDrug
docetaxelDrug
tretinoinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate as measured by RECIST criteria
Time to progression
Secondary outcomes (2)
Survival
Patient-reported symptoms and side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Raghu Nandan, M.D., Inc
- Sponsor type
- University, hospital or other
- Investigators
- Raghu Nandan, MD, Study chair, Raghu Nandan, M.D., Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514293
- Sponsor's protocol ID
- CDR0000561066
- Other IDs
- EISAI-2007-01-22
- Status last verified
- Aug 2008
- First submitted
- 8 Aug 2007
- Last updated
- 10 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00514293
- Acronym / sponsor ID
- CDR0000561066
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Raghu Nandan, M.D., IncUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2011 (estimated)
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Bexarotene and tretinoin may cause tumor cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as cisplatin, carboplatin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bexarotene and tretinoin together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving bexarotene together with tretinoin and combination chemotherapy works in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of bexarotene at a dose of 375 mg daily for 4 days with tretinoin also for the same 3 days with chemotherapy in patients with advanced non-small cell lung cancer.
- Evaluate the safety and tolerability of this drug combination.
OUTLINE: Patients will receive oral bexarotene 375 mg once daily and oral tretinoin 50 mg twice daily on days 1-3. Patients also receive combination chemotherapy comprising cisplatin or carboplatin with docetaxel and capecitabine orally or intravenously on days 1-3. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed every 4 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ECOG performance status 0-2
- Absence of hepatic dysfunction that is characterized by the following:
- ANC ≥ 1,500/mm^3
- Platelets ≥ 100,000/mm^3
- Negative pregnancy test prior to the initiation of treatment
Key exclusion criteria (16 listed)
- Pregnancy, intent to become pregnant, or breast-feeding
- Significant concurrent or intercurrent illness
- Risk factor for pancreatitis (e.g., uncontrolled hyperlipidemia, excessive alcohol consumption, uncontrolled diabetes mellitus, biliary tract disease)
- Untreated hypothyroidism
- Active second malignancy with the exception of carcinoma in situ, early-stage prostate cancer, and squamous or basal cell carcinoma of skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bexarotene | Drug | – |
| capecitabine | Drug | – |
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| docetaxel | Drug | – |
| tretinoin | Drug | – |
Primary outcome
Response rate as measured by RECIST criteria
Time to progression
2 secondary outcomes
Survival
Patient-reported symptoms and side effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raghu Nandan, MD study chair
Raghu Nandan, M.D., Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bexarotene, capecitabine and carboplatin in people with Lung Cancer, run by Raghu Nandan, M.D., Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate as measured by RECIST criteria. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014.