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A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

A Phase II Study of Erlotinib (Tarceva) in Combination With Bexarotene (Targretin) in Chemorefractory Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Erlotinib hydrochloride is designed to help block the activity of an enzyme that is believed
to play an important role in cell growth. Researchers want to find out if blocking these
enzymes will slow tumor growth. Bexarotene is designed to control cancer cell growth and

In order to enroll in this study, you must also be enrolled in Protocol 2005-0823: A
Biomarker-integrated study in Chemorefractory Patients with Advanced Non-Small Cell Lung
Cancer. Protocol 2005-0823 is the screening study in a group of studies called the BATTLE
program. Participants in Protocol 2005-0823 are assigned to one of the research studies.
The results of your tumor analysis helped the study doctor determine to assign you to this
particular research study.

While on study, you will take erlotinib hydrochloride and bexarotene by mouth once a day.
Erlotinib hydrochloride tablets should be taken preferably in the morning 1 hour before or 2
hours after a meal with no more than 7 ounces of water. If you forget to take a dose, the
last missed dose should be taken as soon as you remember, as long as it is at least 12 hours
before the next dose is due to be taken. The next day, you should take the scheduled dose
at the usual time.

Bexarotene capsules should be taken with or immediately after a meal. If you miss a dose,
take it as soon as possible, with food. However, if it is nearly time for your next dose,
skip the missed dose and continue your dose schedule as before.

Every attempt should be made to keep from vomiting the medication for at least 30 minutes
after taking it. For example, if you feel nauseated before or after taking the medication,
anti-nausea medications should be used.

The erlotinib hydrochloride tablets and bexarotene capsules should be stored at room
temperature. Bexarotene capsules should not be stored near heating devices, high
temperatures or humidity, or where children or pets have access to them. Bexarotene
capsules should be protected from sunlight.

Every 4 weeks (1 cycle) your medical history will be recorded and you will have a physical
exam, including measurement of vital signs (blood pressure, pulse, temperature, and
breathing rate) and weight. You will have routine blood tests (about 2 teaspoons) and a
performance status evaluation (questions about your ability to perform everyday activities).
You will have blood drawn (about 1-2 teaspoons) to check you thyroid function. You will
also have blood drawn (about 1-2 teaspoons) to check your lipid profile weekly for the first
4 weeks and then every cycle after that. Your study doctor will also ask you about any
medications you are taking and your smoking history.

Every 2 cycles, your tumor will be evaluated by chest x-ray and computed tomography (CT) or
magnetic resonance imaging (MRI) scans to evaluate the status of the disease. If you are
taking Coumadin® (warfarin), you will have blood drawn (about 1-2 teaspoons) to check your
blood clotting function weekly for the first 5 weeks of treatment and then every cycle after

You may continue receiving erlotinib hydrochloride and bexarotene for as long as the cancer
responds to study treatment. Your doctor may decide to take you off this study if you
experience intolerable side effects, your medical condition gets worse, or you are unable to
comply with study requirements. If you stop study treatment, you may be able to enroll in 1
of the remaining 3 protocols of the BATTLE program.

After you have stopped taking the study treatment, you will have a physical exam, including
measurement of vital signs. Blood (about 2 teaspoons) and urine will be collected for
routine tests. You will also have blood drawn (about 1-2 teaspoons) to check your blood
clotting function. You will have a performance status evaluation, a chest x-ray, and a CT
or MRI scan. Following this evaluation, you will be contacted by telephone every 3 months
for up to 3 years, to see how you are doing.

This is an investigational study. Erlotinib hydrochloride is approved by the FDA for
treatment of NSCLC in patients who have relapsed. Bexarotene is approved by the FDA for the
treatment of cutaneous T-cell lymphoma (CTCL). Their use together in this study is
investigational. Up to 72 patients will take part in this multicenter study. All will be
enrolled at M. D. Anderson.

Inclusion Criteria:

1. The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or
fine-needle aspiration.

2. The patient has a diagnosis of either stage IIIB, stage IV, or advanced, incurable
NSCLC, and failed at least one front-line metastatic NSCLC chemotherapy regimen.
(Patients who have failed adjuvant or locally advanced therapy within 6 months are
also eligible to participate in study).

3. The patient has uni-dimensionally measurable NSCLC.

4. Karnofsky performance status >/= 60 or ECOG performance status 0-2

5. The patient has biopsy accessible tumor.

6. The patient has adequate hematologic function as defined by an absolute neutrophil
count (ANC) >/= 1,500/mm^3, platelet count >/= 100,000/mm^3, WBC >/= 3,000/ mm^3, and
hemoglobin >/= 9 g/dL.

7. The patient has adequate hepatic function as defined by a total bilirubin level 1.5 X the upper limit of normal, and alkaline phosphatase, AST or ALT upper limit of normal.

8. The patient has adequate renal function as defined by a serum creatinine level 1.5 mg/dL or a calculated creatinine clearance of >/= 60cc/minute.

9. The patient has PT < 1.5 x upper limit of normal

10. If patient has brain metastasis, they must have been stable (treated or asymptomatic)
for at least 4 weeks after radiation if treated with radiation and not have used
steroids for at least 1 week.

11. The patient is >/= 18 years of age.

12. The patient has signed informed consent.

13. The patient is eligible if disease free from a previously treated malignancy, other
than a previous NSCLC, for greater than two years. Patients with a history of prior
basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are exempt
from exclusion.

14. Women of child-bearing potential must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Childbearing potential will be defined as women who
have had menses within the past 12 months, who have not had tubal ligation or
bilateral oophorectomy. Should a woman become pregnant or suspect that she is
pregnant while participating in this study, she should inform her treating physician
immediately. The patient, if a man, agrees to use effective contraception or

15. Subject must be considered legally capable of providing his or her own consent for
participation in this study.

Exclusion Criteria:

1. The patient has received prior investigational therapy, chemotherapy, surgery, or
radiotherapy within 4 weeks of initiating study drug

2. The patient has undergone prior thoracic or abdominal surgery within 28 days of study
entry, excluding prior diagnostic biopsy.

3. The patient has received radiation therapy to the measurable tumor within 6 months.
Patients are allowed to have local irradiation for the management of tumor-related
symptoms (bones, brain). However, if a patient has active new disease growing in the
previously irradiated site, the patient will be eligible to participate in the study.

4. The patient has a significant medical history or unstable medical condition (unstable
systemic disease: congestive heart failure (New York Heart Association Functional
Classification class II or worse), recent myocardial infarction within 3 months,
unstable angina, active infection (i.e. currently treated with antibiotics),
uncontrolled hypertension). Patients with controlled diabetes will be allowed.
Patient must be able to undergo procedure for tissue acquisition.

5. The patient has uncontrolled seizure disorder, active neurologic disease, or
neuropathy >/= grade 2. Patients with meningeal or CNS involvement by tumor are
eligible for the study if the above exclusion criteria are not met.

6. The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.

7. The patient has a concurrent condition which in the investigator's opinion makes it
undesirable for the patient to participate in the trial or which would jeopardize
compliance with the protocol.

8. The patient is actively taking herbal remedies or over-the-counter biologics (e.g.,
shark cartilage, high dose antioxidants).

9. Patients will be allowed to have prior biologic (i.e. VEGF, EGFR, etc.) therapy.
However, the patient will be excluded from a given study if he/she has received the
same therapy as the clinical trial (i.e. If a patient has been previously treated
with bevacizumab, they are allowed to enroll in any of the 4 studies. If a patient
has been previously treated with erlotinib, they are excluded from the clinical
trials with erlotinib). In addition, if a patient has been previously treated with
gefitinib (Iressa), they are excluded from the clinical trials with erlotinib.

10. The patient has dysphagia and who is unable to swallow intact capsules.

11. The patient has active gastrointestinal disease or a disorder that alters
gastrointestinal motility or absorption (i.e., lack of integrity of the
gastrointestinal tract such as a significant surgical resection of the stomach or
small bowel).

12. The patient has received prior retinoid derivative therapy.

13. The patient has triglycerides >200.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

8 week Progression-Free Survival Rate (i.e. disease control rate)

Outcome Time Frame:

Reimaging and re-biopsy (optional) of the tumor performed to assess the effects of the drugs on tumor markers after completing 2 cycles of therapy.

Safety Issue:


Principal Investigator

William N. William Jr., MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Erlotinib
  • Tarceva
  • Bexarotene
  • Targretin
  • OSI-774
  • Battle Program
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030