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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: bexarotene (Drug); capecitabine (Drug); carboplatin (Drug); cisplatin (Drug); docetaxel (Drug); tretinoin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Raghu Nandan, M.D., Inc

Official(s) and/or principal investigator(s):
Raghu Nandan, MD, Study Chair, Affiliation: Raghu Nandan, M.D., Inc


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.

Clinical Details

Official title: Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Response rate as measured by RECIST criteria

Time to progression

Secondary outcome:


Patient-reported symptoms and side effects

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- 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


- 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


- 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

Locations and Contacts

R. Nandan M.D. Incorporated, Lakewood, California 90712, United States; Recruiting
Raghu Nandan, MD, Phone: 562-272-7630, Email: traghu9@hotmail.com
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: January 2007
Last updated: January 9, 2014

Page last updated: August 23, 2015

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