Recruiting
Phase 2

Bexarotene, Tretinoin, Chemotherapy

Sponsor:

Raghu Nandan, M.D., Inc

Code:

NCT00514293

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

bexarotene

capecitabine

carboplatin

cisplatin

docetaxel

Study Details

Brief 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.

Conditions

Lung Cancer

Study ID

NCT00514293

Start date

Jan, 2007

Status verified date

Aug, 2008

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

39 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

bexarotene

capecitabine

carboplatin

cisplatin

docetaxel

tretinoin

Primary outcome measure

  • Response rate as measured by RECIST criteria [ Time Frame: undefined ]
  • Time to progression [ Time Frame: undefined ]

Central Contacts and Locations

Locations

R. Nandan M.D. Incorporated

Recruiting

Lakewood, California, United States, 90712

Contacts

Raghu Nandan, MD

562-272-7630traghu9@hotmail.com

More Information

Sponsor

Raghu Nandan, M.D., Inc

Last update posted

Jan 10, 2014

Last verified

Aug, 2008

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Raghu Nandan, M.D., Inc on 2014-01-10.