Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bexarotene
capecitabine
carboplatin
cisplatin
docetaxel
tretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
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
Sites / Locations
- R. Nandan M.D. IncorporatedRecruiting
Outcomes
Primary Outcome Measures
Response rate as measured by RECIST criteria
Time to progression
Secondary Outcome Measures
Survival
Patient-reported symptoms and side effects
Full Information
NCT ID
NCT00514293
First Posted
August 8, 2007
Last Updated
January 9, 2014
Sponsor
Raghu Nandan, M.D., Inc
1. Study Identification
Unique Protocol Identification Number
NCT00514293
Brief Title
Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title
Phase II Trial of Bexarotene (Targretin) Capsules With Tretinoin and Chemotherapy in Patients With Advanced Non-small-cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Raghu Nandan, M.D., Inc
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bexarotene
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
tretinoin
Primary Outcome Measure Information:
Title
Response rate as measured by RECIST criteria
Title
Time to progression
Secondary Outcome Measure Information:
Title
Survival
Title
Patient-reported symptoms and side effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raghu Nandan, MD
Organizational Affiliation
Raghu Nandan, M.D., Inc
Official's Role
Study Chair
Facility Information:
Facility Name
R. Nandan M.D. Incorporated
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghu Nandan, MD
Phone
562-272-7630
Email
traghu9@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
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