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Status unknownNCT00514293Updated Jan 10, 2014

Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

A Phase 2 interventional study of bexarotene and capecitabine in Lung Cancer, sponsored by Raghu Nandan, M.D., Inc. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.

Sponsored by Raghu Nandan, M.D., Inc · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
39
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's planned enrollment of 39 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Raghu Nandan, M.D., Inc is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIB disease with a malignant pleural effusion
    • Stage IV disease
  • Chemotherapy-naive disease
  • Brain metastases allowed provided patients have completed radiation treatment with no actively progressing brain metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • 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
  • 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

Exclusion criteria:

  • 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
  • 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:

Inclusion criteria

  • 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

Exclusion criteria

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrollment
39 participants (estimated)

Interventions

  • Drugbexarotene
  • Drugcapecitabine
  • Drugcarboplatin
  • Drugcisplatin
  • Drugdocetaxel
  • Drugtretinoin
06

What researchers measure

Primary outcomes

  1. Response rate as measured by RECIST criteria

  2. Time to progression

Secondary outcomes

  1. Survival

  2. Patient-reported symptoms and side effects

07

Study locations

1 of 1 sites recruiting
  • R. Nandan M.D. Incorporated
    Lakewood, California 90712, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00514293
Lead sponsor
Raghu Nandan, M.D., Inc
First posted
Aug 9, 2007
Start date
Jan 2007
Primary completion
Dec 2011 (estimated)
Last update
Jan 10, 2014

Study contacts

Raghu Nandan, MD
study chair · Raghu Nandan, M.D., Inc
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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