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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00514293
First received: August 8, 2007
Last updated: January 9, 2014
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: bexarotene
Drug: capecitabine
Drug: carboplatin
Drug: cisplatin
Drug: docetaxel
Drug: tretinoin
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured by RECIST criteria [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Patient-reported symptoms and side effects [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: January 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514293

Locations
United States, California
R. Nandan M.D. Incorporated Recruiting
Lakewood, California, United States, 90712
Contact: Raghu Nandan, MD    562-272-7630    traghu9@hotmail.com   
Sponsors and Collaborators
Raghu Nandan, M.D., Inc
Investigators
Study Chair: Raghu Nandan, MD Raghu Nandan, M.D., Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Raghu Nandan, R. Nandan M.D. Incorporated
ClinicalTrials.gov Identifier: NCT00514293     History of Changes
Other Study ID Numbers: CDR0000561066, EISAI-2007-01-22
Study First Received: August 8, 2007
Last Updated: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Bexarotene
Capecitabine
Cisplatin
Tretinoin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Keratolytic Agents
Dermatologic Agents
Anticarcinogenic Agents
Protective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014